Senior Manager/Associate Director, Quality Control (QC)/Analytical Development (AD)

At Merida Biosciences, we are pioneering true precision medicines for antibody-driven diseases. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity. We are looking for passionate individuals to join our mission to transform treatment paradigms across the spectrum of antibody-driven diseases.

We are seeking a Senior Manager/Associate Director, Quality Control (QC)/Analytical Development (AD) to join our growing, experienced, and collaborative CMC team. In this role you will lead and perform technical and operational aspects of QC/AD activities for antibody and fusion protein products across company’s pipeline through active management of external CDMOs. Successful candidates will be innovative, thrive in a startup environment and use their creative and imaginative problem-solving skills to help deliver transformative therapies to patients.

Key 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.

Qualifications:

• 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 regulation
• 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
• Familiarity with statistical analysis and software tools is a plus.
• 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 

Compensation: We understand that compensation is an important part of considering a new opportunity. Our goal is to be transparent so there are no surprises at the end of the process, and you can feel confident that your offer is both fair and equitable. To support that, we’re sharing our hiring range for this role upfront: typically for the Sr. Manager/Associate Director level we target between $160,000-$190,000. The final offer will take into account a number of factors, including your skills, experience, location, market data, and internal equity. Along with a competitive salary, we’re proud to offer a comprehensive benefits package designed to support you both personally and professionally. 

Merida Biosciences is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.