Associate Director/Director Drug Product Development

Job Description

Job Description

Description:

Associate Director/Director Drug Product Development

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 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 talented Drug Product expert who is interested in joining a highly dynamic team. This position will offer a tremendous opportunity to lead formulation and DP manufacturing for an innovative biologic medicines. Experience in design and scale-up of high concentration formulations for biotherapeutics is critical. Successful candidates will be innovative, thrive in a startup environment and use their creative and imaginative problem-solving skills to help bring new products to patients.

Responsibilities:

• Lead drug product manufacturing process design, optimization, and scale-up across non-GMP and cGMP stages, partnering with DS, QA, and QC to ensure aligned manufacturing timelines.
• Lead selection of and interactions with Contract Manufacturing Organizations to ensure technology transfer and delivery of GMP drug product for clinical studies, including review of MBR and EBR and associated documents. Function as person-in-plant (PIP). Work closely with internal colleagues to ensure timely delivery of drug product supplies for non-clinical and clinical studies as appropriate.
• Collaborate with CMC colleagues to ensure suitable DP platform development and support clinical site engagement (dosage forms, Pharmacy Manual, ancillary assessment).
• Manage the strategy of DP development by planning and executing process characterization and validation activities for late-stage and commercial development, as appropriate.
• Author DP regulatory sections for global filings, including source document reports as needed.
• Develop and implement comprehensive strategies for formulation development both internally and with Contract Research Organizations from early stage through commercial platform, including characterization, pre-formulation, and evaluation of multiple formulation options.
• Author technical reports (formulation development, tech transfer, batch records, etc) and regulatory documents (IND, IMPD, BLA, etc) as necessary.

Qualifications:

• MS/Ph.D. in Pharmaceutics, Material Sciences or related discipline with a minimum 8 years' experience in cGMP manufacturing of biologics.
• Proven track record of developing high concentration biologics drug products. Strong understanding of analytical characterization for biologic molecules (e.g., monoclonal antibody, bispecific antibodies, fc-fusion molecules, etc).
• Experience working with CRO's and CMO's in directing drug product development and manufacturing.
• Ideal candidate will have a strong working knowledge of pre-formulation and formulation of high concentration biologics. Experience working with internal discovery teams and a creative mind for novel ideas to resolve technical issues.
• Goal-oriented team player with excellent communication skills, flexibility, and ability to work in a fast-paced environment with multiple teams across the company.

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 AD/Director level we target $200,000 to $270,000. 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