Kailera Therapeutics, Inc. · Remote-US
Associate Director, Analytical Development and Quality Control
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their ov...
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform
their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working
together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we
seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.
What You’ll Do:
The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for
clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and
will work closely with cross-functional stakeholders to ensure end-to-end drug development and manufacturing activities are
executed seamlessly and in alignment with the company’s integrated development plans and program timelines.
Responsibilities:
- Lead analytical development and support QC activities related to the development and commercialization of peptide drug
substances..
- Develop and maintain current knowledge in analytical methods and product and process control strategies supporting the peptide
drug substance.
- Through our external network, lead the development of analytical methods that support Kailera’s product pipeline, including
analytical transfers and troubleshooting in CDMO laboratories.
- Provide input for developing and implementing analytical development strategies, including managing execution of functional
activities in support of clinical development, regulatory filings (IND/NDA/MAA), product approvals, and commercialization.
- Author relevant CMC sections to enable global regulatory filings.
- Participate on cross-functional CMC teams for the project(s) assigned to ensure adequate development and execution of CMC
plan/strategies as needed.
- Communicate CMC project status to key stakeholders cross-functionally and assist in driving decision-making.
- Collaborate with cross-functional line functions to ensure CMC and program goals are met.
- Travel to CDMOs and other service providers as needed for vendor technology transfers and analytical activities oversight.
Required Qualifications:
- A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug
substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings
(IND/NDA/MAA, etc.).
- Or an advanced degree with 5+ years
- Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy.
Experience in the analytical support of drug substance PPQ/Process Validation.
- Demonstrated analytical project leadership and cross-functional team participation.
- Experience in setting commercial specifications.
- Experience in authoring regulatory documents, including NDA experience
- Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory
requirements, and USP, EP, JP, and CHP requirements.
- Strong understanding of all applicable ICH guidelines.
- Method validation experience.
- Experience with oversight of the analytical activities at CDMOs and/or CTLs.
- Sound problem-solving skills with technically driven decision-making ability.
- Effective written and verbal communication and interpersonal skills.
- Innovative team-player with high energy for our dynamic company environment.
Preferred Qualifications:
- Knowledge and experience in analytical development of injectable products, and associated control strategies
- Knowledge and experience in analytical development of small molecules and solid oral dosage forms.
- Successful support of at least one NDA and commercial launch.
- Synthetic peptide manufacturing knowledge.
- Experience with statistics and applying statistics to analytical chemistry.
- Regulatory Inspection experience.
Education:
- A Bachelor’s degree with 10+ years or an advanced degree with 5+ years of relevant experience
- Degree in Analytical Chemistry, Organic Chemistry, Physical Chemistry, Pharmaceutical Sciences, or closely related field.
Additional Information:
- This position requires some travel to domestic and international destinations.
- In rare occasions, this position may require working in environments where there may be specific gowning or dress code
requirements.
Salary Range
$155,000—$190,000 USD
For Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may
vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage,
flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition
reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your
well-being and future matter to us.
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION:
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race
(including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion
(including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or
gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including
transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability,
genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic
protected by applicable federal, state, or local laws and ordinances.
E-Verify:
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
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Role
Associate Director, Analytical Development and Quality Control
Category
Other
Location
Published
July 22
Deadline
August 22
Source