Associate Director, Process Development Downstream
GENERAL SUMMARY OF POSITION:
Under the general direction of the Director or designee, the Associate Director Process Development is responsible for leading Process Development analytical activities. This position provides technical guidance and leadership to Process Development staff; manages downstream process development projects; prioritizes group tasks and manages resources in order to meet organizational and departmental goals.Responsibilities
- Develop and troubleshoot assays for characterization of MAb and vaccine products.
- Conduct preclinical stability studies and characterize degradation pathways.
- Support upstream and downstream development with spent medium analysis and testing of in-process material.
- Ensure accurate and complete documentation of laboratory activities, suitable for regulatory submissions.
- Write technical reports for tech transfer and regulatory submission.
- Lead the investigation and development of biochemical or biophysical assays that will be used in MAb formulation development, stability studies, and in-depth characterization of purified products.
- Collaborate with and support Product Discovery, Quality Control and other groups within the organization to meet organizational objectives.
- Provide technical and scientific guidance to team members.
- Maintain substantial current knowledge of new analytical technologies and innovations that could be applied to MAb characterization.
- Work with senior leadership team to maintain an environment that fosters teamwork, collaboration, and innovation.
- Hire, manages and trains staff. Plans and assigns duties to meet departmental and organizational objectives. Provide guidance and direction to staff; establishes expectations, defining roles, supporting career development and managing performance.
- Work on problems of diverse scope where analysis of situation or data requires a review of complex data.
- Perform additional job related duties as required.
- Requires a PhD in a relevant scientific discipline such as Chemical Engineering, Biochemistry, Molecular Biology, or other relevant field and a minimum of 5 years of relevant experience.
- Demonstrated technical proficiency, scientific creativity, collaboration with others, and independent thought. Solid knowledge on scientific principles and concepts.
- Must have strong verbal and written communication skills. Ability to communicate effectively with others internally (up, down, and laterally) and externally to the organization.
- Demonstrated ability to manage and prioritize multiple projects and consistently meet deadlines.
- Possesses strong attention to detail, the ability to maintain accurate records and excellent proofreading skills
- Excellent problem solving skills as well as time management and organizational skills.
- Proven ability to manage others, assign and schedule work, and conduct performance evaluations.
- Able to travel as needed
- Previous experience in a cGMP environment
- Experience with Design of Experiment (DOE) software