
Unknown Employer · Sweden
Description Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medi...
Description Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided
by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of
therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of
dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new
possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the
Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to
reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep
understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin
is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and
families around the world. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs
for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians,
scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality
assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support
manufacturing and coordinating the worldwide movement of our drugs to patients. SUMMARY BioMarin is seeking an experienced and
motivated Associate Director to join our Combination Products and Medical Devices team. This role is pivotal, encompassing
strategic and technical responsibilities. This role provides an opportunity to leverage your device development expertise to
develop transformational drug delivery technologies for BioMarin to meet our long-term aspirations. To deliver on this, the
candidate must have a proven track record of success working cross-functionally at senior levels and have experience engaging with
all functions involved with device development. The ideal candidate will exhibit a strong technical background in drug delivery
systems, deep experience in leading cross-functional device team leadership, including experience in combination product
development, device/combination product manufacturing operations, and drug product development, with a proven track record of
successful device/combination product development and commercialization. This role requires managing senior level stakeholders, a
deep understanding of ISO requirements, medical device regulations, and experience in combination products/device development from
inception through commercialization and life cycle management. This role demands a high level of expertise in systems engineering
fundamentals, mechanical product and process design as well as collaborative operation within a cross functional matrix team
environment. RESPONSIBILITIES Lead highly visible cross-functional project teams in developing complex delivery device and
combination product technologies with the goal of clinical introduction, commercialization, and post marketing support. As needed,
lead technology development of unique drug delivery technologies. Partner with key stakeholders like CMC teams, asset teams,
quality, regulatory, external operations and other functions. Lead external device vendor engagement and strategic oversight of
externally developed device technologies. As a device team leader, drive the design, development, verification, validation, and
transfer of combination products and medical devices. Lead product and process improvement related to on market products. Work
closely with contract manufacturers to ensure quality and timely delivery of project deliverables. Prepare and present reports to
senior management on project status, risks, and opportunities. Mentor engineers and scientists within the department. Knowledge of
global regulatory requirements and industry standards. Learn and share knowledge with colleagues and by participating in internal
and external scientific presentation opportunities. Other duties as assigned. EXPERIENCE Required Skills: Minimum 8 years of
experience in the development and commercialization of parenteral combination products and medical devices. Demonstrated ability
to manage cross-functional teams and collaborate effectively with stakeholders. Firsthand experience with parenteral drug delivery
with device technologies like pre-filled syringe, autoinjectors, large volume delivery technologies is highly desirable. Deep
expertise in design controls. Experience working with contract manufacturers. Exposure to human factors engineering. Working with
regulatory agencies and ensuring compliance with industry standards. Effective communication skills and demonstrated ability to
influence up, down, and across multiple levels and functional areas (corporate wide). Desired Skills: Worked at large-mid sized
pharma and/or biotechnology companies focused on developing parenteral combination products. Led cross-functional device teams and
commercialized prefilled syringes, autoinjectors, and/or pen devices Worked with industry standard primary container technologies
like prefilled syringes, cartridges, and vials Experience with lyophilized product related drug delivery EDUCATION Bachelor’s
degree in engineering, Life Sciences, or a related field. Advanced degree preferred. CONTACTS Device engineers, device quality,
device regulatory, external manufacturing, drug product formulation scientists, supply chain engineers, asset team members like
clinical and commercial. ONSITE, REMOTE, OR FLEXIBLE Hybrid. 3 days a week in Novato TRAVEL REQUIRED Up to 10% domestic and
international travel Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It
is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity
Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status
and will not be discriminated against on the basis of disability. Ireland Safety Responsibility Support the organisation’s
commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively
contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in
EHS initiatives and training. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection,
injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally
responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide. When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies. Location: Boston, MA preferred Associate Director, Drug Product Technical Operations Position Summary We are seeking an Associate Director, Drug Product Technical Operations to lead the technical and operational execution of drug product activities across Vor's external manufacturing network. This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content. You will operate at the intersection of technical operations, manufacturing, Quality, Regulatory, Supply Chain, Clinical, and external partner execution. You will serve as the technical owner for Drug Product activities while also driving day-to-day operational execution, with direct impact on product quality, regulatory timelines, supply continuity, and commercial launch readiness. Roles and Responsibilities Drug Product Technical Leadership: Serve as the technical owner for drug product development and manufacturing activities across formulation, compounding, sterile filtration, aseptic fill-finish, visual inspection, container closure systems, and packaging. Apply technical judgment to define manufacturing approaches, evaluate process performance, and resolve complex drug product issues. Manufacturing Operations: Lead planning, readiness, and execution of engineering, clinical, validation, and commercial manufacturing campaigns across external manufacturing sites. Ensure materials, documentation, equipment, methods, and cross-functional decisions are in place to support successful and timely campaign execution. CMC Strategy: Partner with senior leadership to define and execute the Drug Product CMC strategy across development and commercialization. Support decisions related to manufacturing network design, scale-up, process changes, regulatory strategy, technical risk, supply continuity, and lifecycle management. Process Validation and Commercial Readiness: Lead development and execution of drug product validation strategies, including engineering runs, media fills, process performance qualification, hold-time studies, shipping studies, cleaning validation, and continued process verification. Drive readiness for BLA submission, pre-approval inspection, commercial launch, and routine supply. Technology Transfer and Lifecycle Management: Lead drug product technology transfers, process scale-up, site transfers, process improvements, and post-approval changes. Ensure technical requirements, knowledge transfer, comparability considerations, validation needs, and regulatory impacts are clearly defined and executed. Module 3 and Regulatory CMC Ownership: Lead authoring, technical review, and maintenance of Drug Product Module 3 content for INDs, BLAs, supplements, and global regulatory submissions. Partner with Regulatory Affairs and Quality to ensure manufacturing descriptions, process controls, validation strategies, comparability assessments, container closure information, and supporting technical documentation are complete, consistent, and submission-ready. Health Authority and Inspection Support: Support health authority meetings, information requests, regulatory responses, audits, and inspections. Provide clear technical rationale for manufacturing strategies, process changes, validation approaches, deviations, and risk assessments. External Partner Management: Serve as Vor's primary technical and operational interface with Drug Product CDMOs, testing laboratories, and other external partners. Lead technical governance meetings, establish clear expectations, track commitments, and drive timely resolution of risks, issues, and dependencies. Manufacturing Documentation: Review and approve, as appropriate, master and executed batch records, protocols, reports, specifications, change controls, deviations, investigations, CAPAs, risk assessments, validation documents, and campaign summaries. Ensure documentation is technically sound, controlled, and inspection-ready. Deviation and Investigation Leadership: Provide technical leadership for manufacturing deviations, atypical results, batch-impact assessments, root cause investigations, and corrective and preventive actions. Ensure issues are escalated appropriately and resolved using data-driven and risk-based approaches. Drug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements. Cross-functional Collaboration: Partner across Supply Chain, Quality, Regulatory, Clinical, Commercial, Combination Product, Alliance Management, and Program Management to align technical strategy, manufacturing execution, regulatory deliverables, and program milestones. Program Management: Own Drug Product timelines, technical risks, decisions, dependencies, and deliverables. Maintain integrated plans and trackers in Smartsheet and communicate progress through clear timeline views using Office Timeline. Ensure actions, decisions, and documentation are accurate, traceable, and inspection-ready. Skills and Competencies Drug Product Expertise: Strong technical understanding of biologic drug product development and manufacturing, including formulation, aseptic processing, fill-finish, container closure systems, visual inspection, process validation, and commercial manufacturing. Technical and Operational Ownership: Ability to combine technical depth with strong operational execution. Demonstrated ability to independently lead complex activities, manage multiple priorities, and drive programs from strategy through execution. CMC and Regulatory Knowledge: Strong working knowledge of global CMC requirements, Module 3 authoring, process validation, comparability, lifecycle management, and inspection readiness. External Manufacturing Leadership: Proven ability to manage CDMOs and external laboratories, establish accountability, influence partner performance, and resolve technical and operational issues in an outsourced manufacturing model. Education, Experience and Qualifications * Bachelor's degree in engineering, pharmaceutical sciences, chemistry, biotechnology, life sciences, or a related discipline; advanced degree preferred. * 8-12+ years of experience in biologics drug product development, manufacturing, technical operations, process engineering, or CMC. * Demonstrated experience leading aseptic fill-finish activities from development and engineering through process validation and commercial readiness. * Experience leading drug product technology transfers, process scale-up, process validation, manufacturing investigations, change controls, and lifecycle management activities. * Demonstrated experience authoring and reviewing Drug Product Module 3 sections and supporting regulatory submissions, health authority responses, or inspections. * Experience managing CDMOs and external technical partners in a GMP-regulated and highly outsourced manufacturing environment. * Strong understanding of GMP requirements, aseptic processing, validation principles, deviation management, root cause analysis, CAPA, and risk management. * Experience with injectable biologics, prefilled syringes, container closure systems, visual inspection, and combination products is strongly preferred. * Experience supporting BLA readiness, process performance qualification, commercial launch, and post-approval manufacturing changes is preferred. * Strong organizational, program execution, and documentation management skills. The salary range for the Associate Director, Drug Product Technical Operations is expected to be between $170,000 and $195,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location. At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.
POSITION SUMMARY The Business Development Director will be the driver of new business partnerships for Atlas. This position is the tip of the spear for growth and will be responsible for strategically recruiting new physician partners to existing ASC’s, originating opportunities for ASC acquisitions or De Novo projects through physician relationships, developing strategic growth plans in partnership with Operations VP’s, and executing to achieve revenue growth targets. The Business Development Director will build relationships with our in-market operations leaders, key support center internal partners, and our Joint Venture partner to create an aligned winning culture, driving organic revenue growth leading to sustainable market share gains across an assigned market. ESSENTIAL FUNCTIONS * Collaborates with multiple stakeholders, including internal operations and clinical staff, corporate development team, physicians and their respective staff, payer representatives, and all health system employees to articulate the Atlas vision and create value. * Independently Synthesizes and executes upon an in-market growth strategy to identify, segment, source, attract, and convert new leads into case volumes. * Evaluates the current customer base and develops physician alignment and referral networking plans to reach more leads for operational Ambulatory Surgery Center (ASCs) in partnership with Ambulatory Surgery Center Chief Executive Officers and and physician owners. * Develops a physician recruiting strategy in partnership with Ambulatory Surgery Center Chief Executive Officers, physician owners, Vice President of Operations, and corporate development directors according to the needs and service lines associated with each facility/project. * Exhibits strong leadership behaviors and is recognized as the new business physician growth leader for assigned market. * Records data, sales calls, and activity in Customer Relationship Management (CRM) application. * Creates and self-manages a detailed dashboard charting a growth pipeline to achieve revenue goals. * Engages in the entire sales process daily, from lead generation and prospecting through objection handling, closing and customer success. * B2B physician marketing to increase network alignment between our partners and the Ambulatory Surgery Center (ASCs). Acts as liaison between Health System Medical Group and Health System Payor Network and aligned Ambulatory Surgery Center (ASC) specialists. * Networks with medical device, imaging, diagnostic, and all other healthcare sales representatives to identify new leads and growth opportunities. * Identifies opportunities in the market for acquisitions and future developments. * Analyzes physician practices and builds economic models for decision making on profitability. * Provides detailed feedback and delivers customized improvement plans based on physician needs for continuous process improvement both at the ASC and corporate process levels. * Other duties as assigned. Performs all functions according to established policies, procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all customers with an excellent service experience by consistently demonstrating our core and leadership behaviors each and every day. NOTE: The essential functions are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Specific tasks or responsibilities will be documented as outlined by the incumbent's immediate manager. MINIMUM QUALIFICATIONS * Bachelor’s Degree in Business, Communications, Health and Science, or related field. * Demonstrated Track record of success in a direct sales role, preferably in the healthcare industry. * Knowledge of Service Lines/Specialties with relationships usually formed over 5+ years of prior experience in a similar role. * Experience with Microsoft suite applications( Excel, PowerPoint, Word, Outlook). PREFERRED QUALIFICATIONS * MBA/master’s degree in Business, Communications, Health and Science, or related field. * 4+ years of surgical (OR) sales experience * 6+ years leading health-related sales territory/market with direct quota accountability. PHYSICAL DEMANDS/ENVIRONMENT FACTORS This is a field-based position as the primary role is to engage with customers in their place of work. * Requires extensive driving with periodic standing and walking. * May be required to lift up to 20 pounds. * Requires a reliable vehicle (reimbursement plan included) * Requires significant use of computer, phone, and general office equipment. * Needs ability to communicate effectively through reading, writing, and speaking in person or on telephone. * Requires travel to all facilities located with a “market” which may include multiple states or regions. SUPERVISORY RESPONSIBILITIES None DIRECTLY REPORTING Reports to Associate Vice President – Business Development TYPE OF SUPERVISORY RESPONSIBILITIES None SCOPE AND COMPLEXITY This is a field-based position. Must be comfortable working remotely and independently with limited supervision. Must be comfortable with making multiple sales calls daily, developing a plan or roadmap, and executing a plan to achieve revenue growth goals. The role requires the ability to rapidly identify and resolve issues or conflicts and be comfortable with a fast-paced environment. Must possess strong interpersonal skills and be comfortable communicating with executives, physicians, and clinical team members. Must be able to interpret claims data analytics and understand financial models. This role will be responsible for focused and dedicated business development recruitment support for all eligible Ambulatory Surgery Centers (ASCs) targeting high complexity service lines including but not limited to Total Joints, Cardiovascular, Neuro Spine, Ortho Spine, Interventional Spine, and others based on market needs and geographic coverage. This role will be required to cover large geographies spanning multiple joint ventures and states based on business needs.
Description Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. Cosette has a fast-growing portfolio of branded pharmaceuticals consisting of products in the cardiology, women's health, and migraine markets. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories, which has led to consistent supply to customers and commercialization success. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by more than 300 dedicated employees across all functional areas. Innovating every day.™ Position Summary: The Senior Project Manager will contribute to the asset acquisition, integration and transitional service process by providing project level support to Business Development/Alliance Management within the organization. This position will be integral to ensure the smooth operation and integration of acquired/partnered products and working with the Senior Director, Alliance Management, in organizing and reporting project and integration activities. Essential Duties & Responsibilities: Manage projects across technical functions (Product Development, Analytical Research and Development, Clinical, Regulatory Affairs, Technical services, Quality Control, Quality Assurance, launch team) across multiple phases, and different disease areas. Assure continuous consistency of the operational plan with project strategy. Generate and maintain the integrated project plan. Drive option development, including risk analyses, risk mitigation plans, contingencies, identification of opportunities, decision tree generation, and identification of activities on the critical path. Utilize project management methodologies and best practices to help the project teams deliver projects on time and within budget. Publish timely and detailed meeting minutes from project meetings inclusive of associated timelines and pending action items. Ensures execution of all cross-functional project activities. Together with the department head, drive and review project documentation for board meetings according to current guidelines. Build strong alliances with Project Team Members and guide teams through the team development process Serve as neutral facilitator, communicate openly and timely, horizontally and vertically, to achieve transparency of project progress and resolve conflicts in good faith. Provides Project Management leadership in the areas of strategy, planning, tracking, risk management, plan execution, problem-solving, and decision making in line with project strategy and team goals. Proactively plan the resources required to support portfolio priorities and identify risks at portfolio level. Become a subject matter expert in use of the PPM tools, support training of other Project Managers and develop training materials. Qualifications : 5+ years of experience and working knowledge of the pharmaceutical industry with an emphasis on Commercial Project Management. Bachelor's degree in science or engineering, information technology, or other analytics-related disciplines required. Advanced scientific degree (MSc, PharmD, etc.) preferred. Excellent oral and written skills are required. Excellent interpersonal and information management skills and be comfortable interacting with different functional groups and leaders. Expertise in Project Management tools/software (ie. Smartsheet, SharePoint, One Note, Excel, PowerPoint). Relevant experience in drug/device development project management. Demonstrated experience in leading / managing and driving cross-functional teams. Capable of quickly gathering high-level understanding of complex technical, medical, and scientific issues. PMP or equivalent certification is preferred. Salary Range The expected annual base salary for this New Jersey based position is $120,000 - $151,000. In addition, you may be eligible for a discretionary bonus if you are an active employee on the payment date. Benefits Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, health saving account, employee assistance program, tuition reimbursement program, parental leave, wellness program, paid time off, volunteer time, and holidays. Physical Requirements This role will follow a hybrid work schedule, requiring three (3) onsite days per week at our Bridgewater, NJ office. Equal Opportunity Employment Providing “equal employment opportunity” is one of the most important people policies of Cosette Pharmaceuticals, Inc. Our goal is to do all that we realistically can to provide genuine equal employment opportunity to applicants and employees in all phases of our operation. It is the policy of this Company that there shall be no discrimination with respect to employment, or any of the terms and conditions of employment, because of an individual’s race, creed, religion, color, national origin, citizenship, ancestry, age, gender identity or expression, affectional or sexual orientation, marital status, domestic partnership, familial status, atypical hereditary cellular or blood trait, disability (including AIDS and HIV infection), genetic information, liability for service in the United States armed forces or any other legally protected status. The Company is dedicated to ensuring that all employment decisions are in accordance with these principles of equal employment opportunity.