What are the responsibilities and job description for the Senior Scientist, Analytical Development (Drug Product) position at Kailera Therapeutics, Inc.?
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 Principal Analytical Scientist will support analytical development and quality control activities performed by our external partners for cGMP manufacturing, quality release, and stability. The Principal Analytical Scientist will work directly with technical counterparts at vendor sites to implement the required product controls and ensure the integrity of data generated by our external partners. This role will also provide critical support for regulatory filings and ensure compliance with global regulatory standards.
Preferred location : Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).
Responsibilities :
- Participate in the assessment and selection of Contract Development and Manufacturing Organizations (CDMOs).
- Oversee analytical activities conducted by these CDMOs to ensure external partners fullfil technical needs and quality standards.
- Perform detailed review and provide data integrity oversight of data generated at CDMOs.
- Ensure appropriate methods are developed and implemented for drug substance and drug product based on identified critical quality attributes.
- Provide oversight of phase-appropriate method validation activities in alignment with current regulatory requirements.
- Oversee stability programs to support product shelf-life and expiration dating.
- Contribute to the preparation of data summaries and reports, and data review of regulatory submissions (INDs, NDAs, IMPDs).
- Ensure analytical methods and data meet regulatory requirements, generate data to justify specification limits, and assess trends in stability data.
- Ensure all analytical activities comply with GMP, ICH guidelines, and other relevant regulations.
- Participate in internal and external investigations of quality events (e.g., deviations, CAPAs, OOS, etc.).
- Work closely with Manufacturing and Quality Assurance teams to generate cGMP compliant data during product development and manufacturing.
- Provide technical guidance and support to internal teams and external partners.
- Oversee the preparation and review of technical documents, including protocols, reports, and SOPs.
- Ensure data integrity and traceability in all analytical documentation.
Required Qualifications :
Preferred Qualifications :
Education :
Benefits of Working at Kailera
In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.
At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.
Salary Range
115,000-$140,000 USD
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.
LI-Hybrid
Salary : $115,000 - $140,000
