Director Process Development Jobs in California

5+ years managerial experience in drug product development operations;

Provide oversight and innovative leadership for formulation development, process design & development, process scale-up and transfer, and optimization of patient experience;

Thorough knowledge of freezing and thawing of bulk protein solutions and cell therapy products, and freeze-drying processes for protein products;

Strong leadership, interpersonal, communication, and team building skills;

Ability to multi-task and adapt to changing business requirement in a dynamic, matrix environment. Understands business on a global scale;

Prior experience with IND/IMPD submissions for biologics

Deep knowledge of process optimization and development techniques, including familiarity with current industry practices and regulatory requirements.

Extensive experience (at least 10 years) in process development within the biopharmaceutical industry.

Strong scientific leadership skills, demonstrated through publications, presentations, and collaborations within the field.

Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external partners.

Bachelors degree in a scientific discipline, advanced degree preferred

Proven track record of successfully leading and managing teams, with the ability to inspire and motivate individuals to achieve goals.

Manage complex calendar for VP of Process Development

Manage and facilitate agendas for weekly meetings. Responsible for tracking action items within

Bachelor’s degree (or equivalent experience) OR

Associate Degree and 2+ years of administrative experience supporting an Executive Director or VP level OR

High School Degree and 3+ years of administrative experience supporting an Executive Director or VP level

Experience working in a team environment with other administrative assistants

5+ years managerial experience in drug product development operations;

Provide oversight and innovative leadership for formulation development, process design & development, process scale-up and transfer, and optimization of patient experience;

Thorough knowledge of freezing and thawing of bulk protein solutions and cell therapy products, and freeze-drying processes for protein products;

Strong leadership, interpersonal, communication, and team building skills;

Ability to multi-task and adapt to changing business requirement in a dynamic, matrix environment. Understands business on a global scale;

Prior experience with IND/IMPD submissions for biologics

Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Experience leveraging statistical Design of Experiments (DoE) strategies

Progressive years of industry experience in cell therapy drug product process development and/or manufacturing, including formulation, filling, finish, and cryopreservation

Proven ability to build, manage and mentor a team of talented scientists and engineers

Prior experience working on a clinical or commercial cell therapy manufacturing process

Extensive hands-on experience in formulation development and designing and scaling fill/finish and cryopreservation processes, such as aseptic filling and controlled-rate freezing

Author high-quality regulatory submissions and technical reports; independently prepare and present data/findings at department, project team, and senior management meetings

Experience working in a GMP environment and familiarity with quality requirements, USP, and FDA regulations

Excellent data analysis skills and experience with a variety of scientific software applications

Manage tech transfer and process development activities to enable regulatory filing

Performing and supporting in the execution of verification, validation, and performance qualification

Excellent organizational and communications skills and strong ability to lead and work with individuals across all levels in the organization

Excellent data analysis skills and experience with a variety of scientific software applications.

Build and sustain strong relationships with internal and external stakeholders to meet Business requirements.

Experience with different modalities of genetically modified cell therapies (e.g. CAR-T, TCR, HSCs, CD34+, etc..).

Experience in developing & implementing cell therapy manufacturing processes and systems.

Experience with manufacturing genetically modified cell therapy products, ideally both in industry and academia.

Experience in tech transfer and process characterization methods, manufacturing under cGMP, validation, and process comparability in a regulated environment.