Director, Drug Product Manufacturing SME

Director, Drug Product Manufacturing SME

FULLY REMOTE

Job #24-06A

Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs.

The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.

The Director, Drug Product Manufacturing SME is responsible for leading the planning, design and execution of large molecule Drug Product (DP) manufacturing for all stages of development and including validation strategies, and qualifying manufacturing unit operations at the site(s). The individual will also serve as a key process owner in leading CDMOs on manufacturing process improvements, and providing technical leadership through all aspects of DP development, characterization, manufacturing and release. Serves as a large molecule DP technical subject matter expert during quality investigations of complex deviations/non-conformances for DP manufacturing. This position works closely with the CM&C Project Manager, Quality Assurance, and technical teams.

Basic Qualifications

• PhD or equivalent with 10+ years of experience (BS or MS with additional acceptable equivalent experience) in biologics process development; process scale-up; process characterization; technology transfer; process validation; cGMP manufacturing support; and regulatory submissions for protein therapeutics/monoclonal antibodies (mAbs)
• Possesses a deep understanding of biologics DP production, liquid fill and lyophilization development, process characterization process validation activities, and regulatory submission support
• Demonstrated hands-on experience with DP manufacturing/large molecule parenteral activities
• Experience in a management-level leadership role
• Regulatory (FDA etc.) experience in leading dossiers and/or other regulatory communications for DP activities for protein therapeutics/mAbs including PLI/PAI preparation and representation
• Experience in high concentration and/or high viscosity protein solutions and impact to manufacturing processes
• Experience in managing complex biologics DP technical programs for delivery of material to the clinic
• Experience in managing technical and non-technical budgets and timelines
• Experience in managing large molecule DP manufacturing programs, including tech transfer, process characterization, process validation (PPQ) of biological products is required
• Experience in scale up, lifecycle management and commercial planning for large molecules is required
• Experience in leading multidisciplinary teams to successful completion of complex projects under aggressive timelines
• Experience with continuous improvement and operational excellence initiatives
• Experience with lyophilization cycle development/optimization and manufacturing for the clinic and commercial
• Thorough understanding of product development lifecycle of protein therapeutics/mAbs from IND to BLA
• Experience in a management-level leadership role
• Experience with authoring and reviewing CMC documents for multiple regulatory submissions (IND to BLA)
• Excellent collaboration skills and ability to work cross functionally to achieve objectives
• Strong work ethic, motivation, and scientific curiosity

Responsibilities

• Serves as a technical Subject Matter Expert (SME) to the Mapp cross-functional team, specifically in response to large molecule DP manufacturing troubleshooting and technical report reviews
• Leads or assists in the preparation of the technical evaluation of scopes of work, proposals, and reviews vendor responses for DP activities
• Engages and works with internal and external partners (e.g., CDMOs) to ensure all the large molecule drug product processes are robust, scalable, and well characterized before introducing into validation (PPQ) and commercial manufacturing activities
• Collaborates with PI's, PM's, Clinical, Nonclinical, QA, Regulatory, and CMC teams to plan for DP manufacturing needs, timelines, and DP supply
• Oversees manufacturing process designs of multiple large molecule sterile parenteral products for the clinical, process validation (PPQ), and commercial projects
• Assures DP manufacturing plans meet the needs of multiple large molecule programs
• Collaborates with internal and external process development scientists/engineers to deliver large molecule manufacturing processes that meet the speed, yield, and product quality requirements of the development programs
• Develops different large molecule drug product presentations (ie., liquid fills in vials, lyophilization, packaging and labeling activities)
• Leads technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place
• Leads large molecule DP process characterization studies to ensure design spaces, define control strategy for validation (PPQ) and routine manufacturing operation
• Reviews and approves large molecule technical documentation including protocols, master batch records, and reports related to engineering, GMP and PPQ runs
• Leads large molecule manufacturing process validation activities and transfers with external CDMOs ensuring design of validation strategy is in alignment with business needs, regional & global regulatory compliance and support continued process verification post validation
• Supports continuous process improvement and scale up activities to increase yield while maintaining quality attributes for manufacturing process lifecycle management
• Collaborates cross-functionally to support clinical and commercial drug product manufacturing processes, tech transfer, validation, supply/supply chain, shipping, quality/ compliance, change management and product life cycle management
• Ensures regulatory inspection readiness (PLI/PAI) and product compliance with regulatory requirements
• Partners with product development, analytical, manufacturing, quality and regulatory, lead or co-lead quality investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet demand forecast and ensure CAPAs are in place
• Cultivates excellent working relationship with stakeholders to deliver successful manufacturing campaigns
• Compiles metrics and performs analysis of the budget, in parallel with the timelines for Mapp

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. Mapp's anticipated pay scale for this position is $130,000 to $250,000, plus any applicable bonuses. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the candidate's level of education, and type and length of experience within the job and/or within the industry. Medical, dental, and vision insurance benefits are available to eligible employees and their families. Mapp also provides basic life insurance, short and long term disability, and a 401K plan that includes Company contributions to eligible employees. Full time employees will be provided 7 days of sick time, 14 paid holidays, and will also accrue 18 days of vacation throughout the calendar year.

If your job responsibilities allow, you may choose to work remotely. Willingness to Travel (Domestic Travel = 4-6 Trips per year) will be required for this position.

Mapp wants you to join their team and invites you to apply by submitting your information through the Mapp Biopharmaceutical, Inc. Job Openings website page. This job will remain open for twenty (20) days after being posted on Mapp's Job Openings website page.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Mapp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.