
Vor Bio · Boston, MA
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 advanci...
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
advanced degree preferred.
commercial readiness.
change controls, and lifecycle management activities.
authority responses, or inspections.
CAPA, and risk management.
products is strongly preferred.
changes is preferred.
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.
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. Who we are looking for: Vor Biopharma is seeking an Associate Director of Clinical Operations to manage our autoimmune programs. The ideal candidate will initiate and lead clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. The successful candidate will report to the Vice President, Clinical Operations. The Associate Director will also work collaboratively across the therapeutic area and cross-functional teams on the overall development programs and related studies to ensure the successful execution of assigned projects. Experience and knowledge of end-to-end management of clinical trial operations, knowledge of the pharmaceutical industry, and an understanding of clinical drug development and clinical trials operations are essential. Key areas of responsibilities: * Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives * Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs * Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan * Support the selection, oversight, and management of CROs and other vendors * Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team * Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate * Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations * Assist in forecasting clinical trial material and ancillary supplies * Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures * Ensure timely review of protocol deviations and assess the impact on study data * Along with other Clinical Development personnel, represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders * Perform and document study level Sponsor Oversight of outsourced clinical activities * Communicate study status, cost, and issues to ensure timely decision-making by senior management * Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct * Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma * Support program level deliverables/activities at the discretion of the Head of Clinical Operations * Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise * Oversee or conduct routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs and ensure all appropriate documents are filed * Participate and respond to Quality Assurance and/or regulatory authority inspection audits * Facilitate the development of trial budgets and execution of clinical trial agreements and other relevant documents in conjunction with CRO and appropriate internal stakeholders * Manage the clinical trial budget and provide financial reporting and projections to Finance * Lead creation of scope of work and budgets and escalate vendor performance issues to Head of Clinical Operations and Outsourcing as necessary Qualifications: * BA or BS in a scientific, life science, or health-related discipline; advanced degree preferred * Minimum of 8 years of experience in clinical research with at least 5 years of managing trials in the biotech/pharma industry and/or prior CRO experience * Experience in setup, execution, and oversight/operational management of autoimmune trial experience - Sjogren's and/or Myasthenia Gravis experience preferred * Experience working on late-stage studies (Phase II, III) * Excellent communication, writing, and presentation skills with strong problem-solving ability and attention to detail * Strong initiative and a can-do attitude, excellent organizational skills, ability to prioritize deliverables/tasks to meet deadlines, and proven effectiveness in a fast-moving and growing biotech environment * Solid working knowledge of ICH/GCP guidelines and the application to the conduct of clinical trials * Proficient in MS Office Suite and understanding of Clinical Trial Management System, eTMF, and EDC systems, as required * Ability/willingness to travel as required * Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry The salary range for this position is expected to be between $195,000 and $220,000 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.
Founded in 1999, Audax Group is a leading alternative investment manager with offices in Boston, New York, San Francisco, London and Hong Kong. With approximately $42 billion of assets under management and more than 475 employees, Audax is a leading capital partner for middle market companies, operating through three business lines: Audax Private Equity, Audax Private Debt, and Audax Strategic Capital. For more information, visit the Audax Group website www.audaxgroup.com. [https://www.audaxgroup.com] or follow us on LinkedIn [https://www.linkedin.com/company/audaxgroup/posts/?feedView=all]. POSITION SUMMARY: Audax Private Equity deal team members are supported by professionals in several key functional areas including legal, capital markets, finance/accounting, sourcing, portfolio support, IT, and business development. Our model allows deal teams to focus their energy and resources on what matters most – building companies and building equity value for our investors. The Associate will play a key role in the Portfolio Valuation & Analytics team, which focuses on portfolio company valuations, portfolio company / fund level analytics, and investment benchmarking and reporting for the Private Equity business unit. This individual will play a key role in the updating, reviewing, and maintaining of Private Equity investment valuations across multiple funds and strategies. Additionally, the individual will work with other Portfolio Valuation & Analytics team members to maintain the integrity of Audax Private Equity portfolio company data within our portfolio monitoring system, Chronograph. Lastly, the role involves working collaboratively with internal Finance teams and developing reports and analyses to support decision making across the Firm. The ideal candidate is a self-motivated team player with strong technical skills and has experience with private company valuations and preferably Chronograph. RESPONSIBILITIES: Quarterly Valuation & Portfolio Review * Prepare valuation models for quarterly update process and co-ordinate with investment team members to ensure deadlines are achieved and models function as intended. * Ensure all completed valuation models adhere to relevant accounting standards as well as internal policies and procedures. * Assist in creation and updating of quarterly Valuation Committee presentation materials including details on portfolio company metrics, fund performance analyses and benchmarking analyses. * Update and maintain quarterly valuation summaries as required by co-investors. * Work in conjunction with the portfolio support team to update presentation materials for internal portfolio reviews, including industry specific analyses. * Stay up-to-date with industry best practices, market trends and regulatory changes affecting investments. Maintenance of private equity portfolio company databases * Maintain and ensure integrity of all portfolio company and fund level metrics stored within Chronograph, Audax’s portfolio monitoring platform. * Understand functionality of Chronograph and provide support to other users within the firm. * Work directly with portfolio company management teams as well as investment team members to collect relevant company metrics and materials and review for correctness. * Co-ordinate with Business Development and Analytics team members to confirm consistency of data across different internal platforms and databases. Process re-engineering and automation to promote efficiency and accuracy * Execute operational improvements. Coordinate with portfolio support team, finance, and IT to refine centralized databases and business intelligence processes to improve quality and control of data for reporting and analysis. * Document work streams and offer recommendations on efficiency. REQUIREMENTS/QUALIFICATIONS: * BS or BA with a high GPA in Finance, Accounting, Economics or a related major * 3-5 years' experience in an analytical role including work with integrated financial statement models, valuation experience preferred * Understanding of investments, LBO / M&A transactions and private company valuations * Strong organizational skills with the ability to multitask * Strong interpersonal and communication skills * Experience with Chronograph, iLevel, Dynamo, PowerBI, Capital IQ and / or investment analytics software a plus The candidate should be advanced in Excel and PowerPoint, specifically in the following areas: * Complex logic formulas and advanced combinations of lookup functions * Financial and performance functions (e.g. xirr) * Macros, filters, data tables and pivot tables * Strong PowerPoint presentation skills with attention to detail and ability to summarize complex ideas to various audiences LOCATION: Boston, MA. 3 days/week in office. These in office requirements may change based on the needs of the business. OTHER DUTIES: For Massachusetts: The base salary range for this position is $80,000 - $115,000. The base salary range represents the estimated low and high end for this position at the time of this posting. Consistent with applicable law, compensation may vary and will be determined based on but not limited to, the skills, qualifications, and experience of the applicant along with the requirements of the position, and Audax reserves the right to modify this pay range at any time. An employee may also be eligible for annual discretionary incentive compensation based on performance. Audax offers a wide range of employee benefits, including health insurance, life insurance, disability insurance, paid time off (including sick leave, parental leave, volunteer leave, and vacation), charitable donation match, family support services (including Bright Horizons and Benefit Advocate Center), and a 401(k) in addition to other benefits. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned at any time with or without notice. Audax Management Co. is an equal opportunity employer. Please note that Audax Group and its affiliated entities do not accept unsolicited resumes from a third-party recruiting agency not currently under a signed agreement. Any unsolicited resume that is sent to directly to Audax Group or one of its affiliated entities, or its employees, including those submitted to hiring managers by a third-party recruiting agency not currently under a signed agreement, will be considered property of Audax Group. If a third-party recruiting agency submits a resume without an agreement, Audax Group or its affiliated entities explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the third-party recruiting agency. Any third-party recruiting agency should contact either a member of the Talent Acquisition or Human Resource team at Audax Group, in conjunction with a valid, fully executed contract for service based upon a specific job opening.
Waverly Advisors’ primary goal is to serve our clients, one another, and our communities. We aren’t your typical wealth management firm. Our intense client focus is at the center of everything we do. We go far beyond just managing our clients’ investments, offering truly in-depth financial planning. We set ourselves apart by actually living and acting on our guiding principle, ‘Serve.’ It is the reason we go to work every day. In this role, you’ll be challenged to take on work that upholds our guiding principle and drives Waverly Advisors forward. We hope you’ll grow as a person and leader in your field and transform those around you as well. We are looking to add an experienced Client Service Associate to the team in our Boston, MA office. The Client Service Associate is an essential part of the Waverly Advisors team, regularly serving as the liaison between clients and advisors/financial planners, as part of our overall client experience. A successful candidate will have the ability to effectively communicate with clients and team members, excellent attention to detail, strong written and verbal communication skills, an energetic and positive attitude, and a willingness to learn. Organizational skills, resiliency and flexibility, promptness, and the ability to anticipate needs are necessary in all tasks and responsibilities. Responsibilities: * Serves as a primary point of contact for clients and assists Wealth Advisors in developing and maintaining client relationships. * Provides all client service support including account applications, custodial paperwork, investment advisory agreements and money movements. * Responds to all internal and external client requests in a timely manner. * Processes all documents from clients including advisory agreements, account applications or other custodial paperwork. * Assists in all meeting preparation including binding and preparing presentation materials. * Coordinates with Private Fund team on any alternative investment subscriptions and redemptions. * Works directly with a variety of financial custodians (Schwab and Fidelity) to establish, maintain and update all new and existing client accounts. * Tracks and updates client-related information in SharePoint and Salesforce including but not limited to contact information, investment advisory agreements, client-related notes and correspondence and other relevant information or documentation. * Tracks information sent to financial custodians for verification of receipt and completed work. * Assists with tracking client money movement requests and communicating that information to Advisors. * Notifies Wealth Advisors if trades are needed related to client money movement requests. * Processes Required Minimum Distributions (RMD’s) for clients on an annual basis. * Follows Waverly compliance policies and procedures related to client requests and other matters. * Administrative duties as needed. Qualifications and Experience: * Bachelor’s degree in Finance, Business, or a related field, or, in lieu of a college degree, 5 years of experience in financial services. * Experience with Schwab, Fidelity, and Pershing preferred. * Familiarity with portfolio accounting systems and client relationship management software is preferred. * Proficiency in Microsoft Office. Competencies and Skills: * Proactive, team player who values building positive relationships with clients and colleagues. * Detail-oriented self-starter. * Highly organized. * Strong verbal and written communication skills. * Can-do attitude where no task is too big or small. * Ability to juggle demands of multiple people and deadlines. * Positive attitude with a willingness to learn. Travel: * Minimal travel is required. Physical Requirements: * Prolonged periods of sitting at a desk and working on a computer. * Must be able to lift 15 pounds at times. * Must be able to access and navigate each department at the organization’s facilities. Benefits: * Comprehensive Health, Dental, and Vision coverage to support your overall well‑being. * 401(k) retirement plan with match and profit sharing to help you invest in your future. * Twelve paid holidays each year. * An extra vacation day during your birthday week—so you can celebrate you! * Responsible Time Off Policy giving flexibility without annual PTO limits, while balancing team responsibilities and business needs. * Paid sabbatical program: Enjoy four consecutive weeks of paid time off after seven years of service. * Compensation commensurate with experience. Legal: Waverly Advisors, LLC. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, gender, genetic information, national origin, disability, uniform service, veteran status, age, or any other classification protected by federal, state, or local law.