Director of Drug Product Development

The Director of Drug Product Development will plan, supervise, and support the development and manufacturing of multi-component biologics while working closely with CDMOs. Responsible for drug product development and the GMP manufacture of therapeutic candidates from development through commercialization. Responsible for managing external operations of vendors and providing oversight of the outsourced activities while operating in a virtual environment. Skilled in late phase process development, characterization and validation, quality, and CMC documentation for regulatory submissions. This role requires full collaboration with drug substance manufacturing, analytical development, quality assurance, and regulatory affairs teams.

Principal Duties and Responsibilities include the following:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management.

Drug product process development and manufacturing

Lead end-to-end process development and manufacturing of co-formulated drug products to support clinical trials, registration (e.g., BLA), and commercial launch.
Design and optimize scalable formulation and fill/finish processes, including in-process controls, characterization, and stability programs; oversee GMP manufacture of clinical lots.
Build and manage integrated timelines and budgets for formulation development, scale-up, tech transfer, and manufacturing to meet clinical supply and registration goals.
Integrate drug substance, drug product, analytical testing and device requirements into CMC strategies and plans aligned with corporate objectives.
Plan and execute process optimization, characterization and validation strategies (protocols, reports) and readiness for continued process verification.
Select, qualify, and manage CDMOs/CROs and consultants; establish SLAs, oversee performance, and drive issue resolution.
Plan and oversee any technology transfer manufacturing operations to new CDMOs ensuring that transfer, validation and regulatory outcomes are met.
Lead cross-functional collaboration with Analytical Development, Technical Operations, Manufacturing, QA, Regulatory Affairs, Clinical Development, and Program Management.
Manage a portfolio of projects, set priorities, and deliver on scope, schedule, and budget

Clinical supply materials

Management of drug product inventory and product supply to satisfy clinical development, including monitoring drug product shelf-life, and managing drug product shelf-life/expiration extension programs.
Direct internal and external GMP manufacture and supply of drug products to ensure timely supply of materials needed for clinical trials.
Manage product and raw material specifications and product shelf-life/stability protocols.

Quality, Regulatory

Author, review, and approve pharmaceutical development reports and CMC sections for regulatory submissions (IND/IMPD, BLA/MAA) and briefing packages.
Adhere to QbD principles and cGMP work practices and work closely with the Quality department to ensure strict compliance with applicable GxP procedures and compliance requirements.

Supporting & collaborative activities

Collaborate with Analytical and QC the GMP sample handling, testing, QC stability program, QC release and stability data analyses and method data trending, OOE/OOS investigations and support Certificates of Analysis generation of clinical supply materials.
Drive continuous collaborative activities with analytical development, technical operations, QA, regulatory affairs, clinical development, and program management, as well as external vendors (CROs and CDMOs).
Support and collaborate with Analytical Development in the development of methods and assays to test the properties of biological drug formulations and ensure the quality of manufacturing processes. Provide support in the evaluation of method validation, method transfer, DS and DP testing, life cycle management and investigations for multiple biologics assets.
Ensure high quality science, technology, deliverables, and collaborates to ensure compliance with global regulatory and quality requirements.
Participate in meetings with Regulatory Authorities, respond to regulatory queries, and participates in Pre-Approval Inspections as needed.

Supervisory Responsibilities

Direct reports: to be defined as the team grows
Indirect Reports: supervise CDMO, CRO and external resources (i.e. consultants)

Qualification Requirements

Education:

Master's or Ph.D. degree in Pharmaceutical Sciences or a related field

Experience:

8 years minimum experience in the pharmaceutical or biotechnology industry in the field of pharmaceutical development with emphasis in biological drugs, with strong preference for antibody drugs, including process development and manufacturing of biological drug substance, drug product, formulation development and analytical testing.
Broad knowledge of all aspects of CMC including process development, regulatory and quality requirements, analytical development, formulation, and drug product technologies.
Demonstrated experience in the field of liquid and lyophilized biological drug formulations with exposure to combination products, and injectable dosage forms is preferred.
Comprehensive understanding of injectable dosage formulation development processes, manufacturing process development, scale-up, optimization and validation processes.
Extensive knowledge of cGMP/GLP ICH and FDA guidelines.
Experience in INDs and BLAs submissions.
Experience managing CROs and CDMOs.
Expert knowledge of advanced principles, concepts, and theory related to product and process development.
Oncology and/or combination drug/device experience preferred.

Knowledge/Skill:

Candidates proficient in both English and Mandarin are highly encouraged to apply.
Excellent leadership, organizational and project management skills.
Ability to work on multiple projects simultaneously with flexibility to take on new challenges as needed.
Must have outstanding communication and collaboration skills within cross-functional teams and external organizations.
Demonstrated ability to write technical and scientific documents.
Ability to work in a fast-paced virtual environment.
Excellent verbal and writing skills.
Excellent editing and proof-reading skills.
Possess a self-directing, self-starting work ethic.
Excellent knowledge of the competitive environment for drugs in the immuno-oncology marketplace and in research and development pipelines.
Flexibility to travel domestically and internationally.

Working Conditions

Specify work environment:

The work environment shall be split between a virtual office environment and the Company headquarters in Fort Lauderdale, FL.
Domestic and international travel up to 15% of time
Ability to lift up to 25 pounds
Regularly required to stand, sit, talk, hear, and use hands
Prolonged periods of sitting and standing

Syncromune is an Equal Opportunity Employer.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range: $230,000-$250,000

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.