Associate Director Validation Jobs in Hialeah, FL

The Associate Director of Drug Product Development supports the planning and execution of the overall drug product (DP) development strategy from clinical development through commercialization for multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides. This role provides technical expertise and operational oversight for formulation development, formulation and process robustness characterization, GMP manufacturing, process and product characterization, process validation, and commercial readiness while working closely with external CDMOs.
The Associate Director is responsible for planning, supervising, and supporting drug product development activities throughout the product lifecycle and overseeing outsourced development and manufacturing activities in a virtual operating environment. This position ensures high-quality execution, adherence to project timelines, and compliance with regulatory and quality requirements across formulation development, process optimization, robustness characterization, GMP production, technology transfer, process characterization, process validation, and commercial manufacturing.
The successful candidate should possess demonstrated expertise in formulation development for biologics, formulation and process robustness characterization, late-phase process development, process characterization and validation, technology transfer, GMP manufacturing, quality systems, and CMC documentation to support global regulatory submissions. Experience with Design of Experiments (DoE), Quality by Design (QbD), and risk-based process development approaches is highly desirable. This role requires close collaboration with Drug Substance Manufacturing, Analytical Development, Quality Assurance, Regulatory Affairs, Supply Chain, and other cross-functional teams to advance therapeutic candidates from development through commercialization.
Principal Duties and Responsibilities include the following:
Drug Product Formulation Development

• Serve as the technical subject matter expert (SME) for formulation development of multi-component biologic drug products, including monoclonal antibodies (mAbs) and synthetic oligonucleotides, supporting development from clinical through commercial stages.
• Support the planning and execution of the overall drug product development strategy with primary responsibility for formulation development and formulation lifecycle management.
• Supervise CDMO to execute formulation development activities such as formulation optimization, compatibility assessments, and forced degradation studies.
• Supervise CDMO to execute formulation robustness characterization by evaluating formulation design space (DOE), critical formulation parameters, stress conditions, and manufacturability to establish stable, scalable, and commercially viable drug product formulations.
• Develop formulation control strategies based on product knowledge, risk assessments, Quality by Design (QbD) principles, and regulatory expectations.
• Collaborate closely with Drug Substance Development, Analytical Development, Device Development, and Manufacturing teams to ensure formulation compatibility, product performance, manufacturability, and lifecycle management.

Drug Product Process Development and Manufacturing

• Execute process development, scale-up, technology transfer, and GMP manufacturing activities by providing technical leadership and oversight to CDMOs throughout clinical and commercial development.
• Support process optimization, process characterization, process validation, continued process verification (CPV), and lifecycle management through development, review, and execution of protocols, reports, and technical documentation.
• Integrate formulation characteristics, process capability, and critical quality attributes (CQAs) to establish robust manufacturing processes and commercially viable control strategies.
• Supervise and manage CDMOs and CROs; monitor performance, resolve technical and operational issues, and ensure delivery of project objectives.
• Support technology transfer to manufacturing partners, ensuring successful process transfer, engineering runs, process validation, regulatory compliance, and commercial readiness.
• Oversee CDMOs in executing GMP manufacturing programs by coordinating cross-functional activities and providing technical oversight to manufacturing partners to ensure timely production of clinical and commercial drug products.
• Manage multiple development programs simultaneously, ensuring delivery against technical, quality, regulatory, timeline, and budget objectives

Cross-function Collaboration

• Collaborate closely with Drug Substance Development, Analytical Development, Quality Assurance, Regulatory Affairs, Manufacturing, and external partners to ensure successful execution of drug product development, technology transfer, validation, and GMP manufacturing activities.
• Support Analytical Development to develop, qualify, validate, transfer, and lifecycle-manage analytical methods supporting formulation development, process characterization, release testing, stability studies, and product lifecycle management.
• Work closely with Quality Assurance to ensure compliance with Quality by Design (QbD) principles, cGMP, quality systems, and global regulatory requirements throughout the product lifecycle.
• Support Regulatory Affairs by authoring and reviewing CMC documentation (IND, BLA), preparing technical content for regulatory submissions, responding to health authority inquiries, and participating in regulatory inspections and Pre-Approval Inspections (PAIs), as needed.

Supervisory Responsibilities:
Indirect Reports: supervise CDMO, CRO and external resources (i.e. consultants)
Qualification Requirements:
Education:

• Ph.D. or M.S. degree in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or a related scientific discipline

Experience:

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Bioengineering, or a related scientific discipline with a minimum of 5 years of relevant biopharmaceutical industry experience; or M.S. in a related scientific discipline with a minimum of 10 years of relevant biopharmaceutical industry experience.
• Demonstrated experience in biologic drug product development, with expertise in formulation development, formulation robustness characterization, process development, technology transfer, and GMP manufacturing. Experience with monoclonal antibodies is strongly preferred; experience with oligonucleotide therapeutics is highly desirable.
• Extensive knowledge of formulation development for liquid and lyophilized injectable products, including formulation optimization, stability assessment, manufacturability, and commercial product lifecycle management.
• Strong understanding of drug product process development, scale-up, process characterization, process validation, continued process verification (CPV), aseptic fill/finish manufacturing, and commercial manufacturing readiness.
• Broad knowledge of Chemistry, Manufacturing and Controls (CMC), including drug substance and drug product development, analytical development, quality systems, regulatory requirements, and manufacturing technologies.
• Working knowledge of combination products, prefilled syringes, autoinjectors, and other injectable drug delivery systems is preferred.
• Extensive knowledge of cGMP, GLP, ICH guidelines, FDA regulations, and other applicable global regulatory requirements.
• Demonstrated experience authoring and supporting CMC documentation for regulatory submissions, including INDs, BLAs, IMPDs, and/or MAAs.
• Proven experience managing external development and manufacturing partners, including CDMOs, CROs, and technical consultants, in a virtual development environment.
• Demonstrated technical expertise in applying Quality by Design (QbD), risk management, and Design of Experiments (DoE) principles to drug product development.
• Experience in oncology, immuno-oncology, and/or combination drug-device products is preferred.

Knowledge/Skill:

• Strong scientific and technical expertise in biologic drug product formulation development, process development, manufacturing, and CMC development.
• Excellent verbal, written, presentation, technical writing, editing, and scientific communication skills.
• Demonstrated ability to collaborate effectively with cross-functional teams and external partners, including Drug Substance Development, Analytical Development, Manufacturing, Quality Assurance, Regulatory Affairs, and CDMOs.
• Strong analytical and problem-solving skills with the ability to independently evaluate complex technical issues and develop practical, science-based solutions.
• Demonstrated ability to provide technical oversight and scientific guidance to external development and manufacturing partners in a virtual development environment.
• Self-motivated, detail-oriented, and capable of working effectively in a fast-paced, collaborative, and matrixed environment.
• Knowledge of Quality by Design (QbD), risk-based development, Design of Experiments (DoE), and applicable ICH, FDA, and global regulatory expectations for biologic drug products.
• Knowledge of the competitive landscape, emerging technologies, and regulatory trends in biologics and immuno-oncology drug development is desirable.
• Proficiency in both English and Mandarin is highly desirable.
• Willingness to travel domestically and internationally as business needs require.
• Willingness to work flexible hours, including early morning and late evening/night meetings, to effectively collaborate with global teams, CDMOs, CROs, and business partners across multiple time zones.

 Working Conditions:          

1. Specify work environment:

• Work from home.
• Support collaboration with non-U.S. CDMO partners by accommodating meetings outside core working hours, including early morning, evening and/or nighttime sessions when necessary
• Domestic and international travel up to 25%.
• Regularly required to stand, sit, talk, hear, and use hands, with 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 for Assoc Director and Director levels:  $165-$205K

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

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