Merida Biosciences · 1 day ago
Senior Manager/Associate Director, Quality Control / Analytical Development
Cambridge, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$160K/yr - $190K/yr
6+ years expMerida Biosciences is pioneering true precision medicines for antibody-driven diseases, and they are seeking a Senior Manager/Associate Director to lead QC/Analytical Development activities. The role involves overseeing CDMOs for method development, managing stability programs, and collaborating with the CMC team to deliver transformative therapies.
BiotechnologyLife ScienceTherapeutics
Responsibilities
Oversee CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for drug substance (DS) and drug product (DP) in-process, release and stability testing. Review method development plan, qualification/validation protocols, test procedures, raw data, and technical reports and manage the activities to meet the project timeline
Manage stability programs through CDMO, design stability studies, review stability protocol and data, manage data delivery timeline, monitor trends, troubleshoot QC method performance, and investigate OOT/OOS
Review quality documents (protocols, reports, specifications, CoAs, executed batch record etc) and quality events/records (change controls, deviations, CAPAs, etc)
Build and maintain a mature QC infrastructure, implementing procedures to support the development of therapeutic candidates in a GMP-compliant manner
Author and review relevant CMC sections for regulatory filings (IND/CTA/BLA/MAA). Contribute to the responses to health authority’s questions
Work closely with key personnel within CMC team including Process Development, Formulation, DS and DP Manufacturing, Quality, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories to execute QC/Analytical development activities according to program needs and participate in external lab due diligence visits and audits as needed
Qualification
Required
Bachelor's Degree with 8+ years or PhD or MS in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 6+ years of relevant industry experience in biologics drug development, particularly monoclonal antibodies and Fc-fusion proteins
Expertise/competence in analytical techniques for biologics such as HPLC, CE-SDS, icIEF, spectroscopy, ELISA, cell-based bioassays and LC-MS etc. Strong cell-based bioassay experience is a plus
Strong working knowledge and understanding of cGMP/ ICH/ FDA/ EU guidance and regulations
Prior experience of managing/partnering with CDMOs and third-party testing sites for analytical development and QC activities
Proven track record of managing all aspects of DS and DP stability programs
Experience of managing quality events such as OOT/OOS, deviations, change control etc
Strong experience of authoring and reviewing analytical methods, method qualification/validation protocol, technical reports, quality documents and regulatory filing documents for IND/CTA/BLA/MAA
Excellent interpersonal and communication skills and demonstrated ability to effectively collaborate across functional lines in a team-oriented environment
Ability to work independently as well as in a team environment and multi-task in a fast-paced organization
Preferred
Strong cell-based bioassay experience is a plus
Familiarity with statistical analysis and software tools is a plus
Benefits
Comprehensive benefits package designed to support you both personally and professionally
Company
Merida Biosciences
Merida Biosciences is a biotech company focused on developing precision treatments, particularly for autoimmune diseases.
11-50 employees
H1B Sponsorship
Merida Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
Funding
Current Stage
Early StageTotal Funding
$121MKey Investors
Third Rock Ventures
2025-04-08Series A· $121M
2022-01-01Seed
Company data provided by crunchbase