Director of Drug Substance Development Position Available In Broward, Florida

Director of Drug Substance Development Syncromune, Inc. Fort Lauderdale, FL The Director of Drug Substance Development will lead and manage the development and manufacturing processes of different biological drug substances, focusing on technology transfer, scale-up, process characterization, and process validation at various Contract Development and Manufacturing Organizations (CDMOs). This role requires close collaboration with internal teams and external partners to ensure the successful development and commercialization of therapeutic candidates. The ideal candidate will possess extensive experience in biological drug substance development, process optimization, process characterization, process validation and regulatory compliance. This role requires full collaboration with drug product development and manufacturing groups, analytical development groups, manufacturing operations, quality assurance, and regulatory affairs teams.

Responsibilities:

The following is not intended to be an all-inclusive list of responsibilities. Other activities may be assigned as required by management. Process Development and Optimization Oversee the development and optimization of scalable processes for the production of biological drug substances, ensuring efficiency, yield, and purity. Integrate knowledge of physical chemical properties, process engineering, and analytical chemistry to design robust manufacturing processes. Implement Quality by Design (QbD) principles and adhere to current Good Manufacturing Practices (cGMP) to ensure compliance with regulatory standards. Work closely with the Quality department to ensure strict compliance with applicable GxP procedures and compliance requirements. Prepare pharmaceutical development reports and other technical documentation required for regulatory submissions, including authoring, review, and approval of requisite sections of the IND, BLA, briefing packages or other regulatory submissions. Develop timelines and budgets for formulation development, scale-up, and manufacturing to meet clinical supply and registration needs. Ensure technology transfer, validation and regulatory outcomes are met. Technology Transfer and Scale-Up Participate in selection and qualification of CDMOs involved in manufacturing of drug substance, manage external vendors, such as consultants, CROs and CDMOs throughout product development early life cycle. Lead technology transfer activities to and from CDMOs, ensuring seamless transition of processes and methodologies. Plan and supervise scale-up activities to support new manufacturing processes needed to support clinical trials, registration, and commercial product launch. Develop risk-based strategies for technical oversight, considering product lifecycle, technical complexity, and CMO capabilities. Process Characterization and Validation Design and execute process characterization studies to identify critical process parameters and establish control strategies. Develop and oversee process validation plans, including drafting necessary protocols and reports to ensure regulatory compliance. Collaborate with cross-functional teams to ensure alignment on process validation strategies and timelines. Plan and supervise drug substance manufacturing process optimization, define in-process controls and critical quality attributes, stability programs, early GMP manufacturing and characterization of clinical lots. Plan and oversee the strategy and individual steps needed for drug substance manufacturing process characterization and process validation, drafting all necessary protocols and reports. Support continuous collaborative state with analytical development, technical operations, manufacturing, QA, regulatory affairs, clinical development, and program management, as well as external vendors (CROs and CDMOs). Plan and supervise late-stage drug substance manufacturing activities to support drug product manufacturing of coformulations for clinical use, from early stage to BLA and commercial stage. Develop timelines and budgets for manufacturing processes, scale-up, and manufacturing to meet clinical supply and registration needs. Manage multiple projects and contribute to project prioritization, project timelines to ensure efficiency with respect to time, and budget. Oversee in collaboration 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. Clinical Supply Materials Management of drug substance inventory to satisfy the demand of drug product manufacturing necessary for clinical development, Monitor drug substance stability, and managing drug substance retesting and expiration extension programs. Direct internal and external GMP manufacture and supply of drug substance to ensure timely supply of materials needed for clinical trials. Manage product and raw material specifications and product shelf-life/stability protocols. Quality, Regulatory Prepare manufacturing development reports and other technical documentation required for regulatory submissions, including authoring, review, and approval of requisite sections of the IND, NDA or other submissions. 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. Participate in meetings with regulatory authorities, respond to regulatory queries, and support pre-approval inspections as needed. Supporting & Collaborative Activities Drive continuous collaborative activities with analytical development, technical operations, manufacturing, 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 drug substance and ensure the quality of manufacturing processes. Develop timelines and budgets for process development, scale-up, and manufacturing to meet clinical supply and registration needs.

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, Chemical Engineering, Biochemistry, 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 and oligonucleotides including process development and manufacturing of biological drug substance. Demonstrated experience in process development, scale-up, technology transfer, and process validation for biological drug substances. Extensive knowledge of cGMP/GLP ICH and FDA guidelines. Experience in INDs and BLAs submissions. Experience managing CROs and CDMOs. Proven track record in authoring technical and scientific documents for regulatory submissions Expert knowledge of advanced principles, concepts, and theory related to product and process development.

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. Outstanding communication and collaboration skills within cross-functional teams and external organizations. Ability to work in a fast-paced virtual environment. Flexibility to travel domestically and internationally as required Excellent leadership, organizational and project management skills.

Working Conditions:

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 25% 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.