Manager/Sr. Manager, Downstream Process Development and Manufacturing

Job Description

Job DescriptionDescription:

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.

Position Summary
We are seeking a Manager/Sr. Manager, Downstream Process Development and Manufacturing, to join our experienced, professional and collaborative CMC team. This role offers a unique opportunity to advance clinical programs by leading downstream process development, process optimization, tech transfer and GMP production activities through active management of external CDMOs. The ideal candidate will be innovative, thrive in a startup environment and bring creative problem-solving skills to help deliver transformative therapies to patients.

Key Responsibilities

• Collaborate cross functionally with discovery, non-clinical, clinical, and CMC teams to develop and deliver phase-appropriate materials for animal and clinical studies.
• Develop robust downstream process for novel protein therapeutics for early/late-stage development.
• Oversee CDMOs for phase appropriate downstream process development, including chromatography-based and filtration-based unit operations.
• Author and review development plans, study protocols, technical reports and data packages; monitor progress and manage risks.
• Oversee scale-up activities to support smooth technology transfer and GMP manufacturing. Review development report, process description document, Risk registers, BOMs, PFDs, and batch records, manage deviation investigations. Act as person in plant for key GMP events.
• Participate in contract reviews and change order negotiations.
• Author and review regulatory documents (IND, IMPD, etc.)
• Support other CMC activities as needed.

Requirements:

• Ph.D., M.S., B.S., or B.E. in Chemical Engineering, Biology, Biochemistry, or related discipline.
• Ph.D. with 3+ years, M.S. with 5+ years, or B.S. with 8+ years of relevant industry experience in downstream process development.
• Hands-on experience in downstream process development, technology transfer and manufacturing processes using Quality-by-Design (QbD) principles and DoE designs.
• Strong working knowledge of cGMP and experience reviewing batch records.
• Experience with late phase process development is a plus.
• Experience managing CDMOs and negotiating change orders is a plus.
• Familiarity with statistical analysis and software tools is a plus.
• Goal oriented team player with excellent communication skills, adaptability, and ability to thrive in a dynamic, fast-paced environment.

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.