Job details
Job type full-time
Full job description
Title: director/senior director, formulations
Reports to: executive vice president, analytical sciences & formulations
Location: camarillo, ca
Classification: exempt
Overview:
Provide strategic and technical leadership for the development of novel formulations, and activities required for ind applications, product licensure and gmp compliance.
The successful candidate will design key experiments, direct, prepare and review protocols, data and study reports, oversee activities at contract labs, prepare summaries and presentations and communicate results to technical, development and legal managementThis position will work closely with leaders and scientists in analytical development, process development, manufacturing and quality groups to provide technical insights and support of new product development to meet corporate goals and objectivesThe director/senior director of formulation development will also be a scientific resource during the manufacturing of new products to support process development, scale-up, analysis of new findings and troubleshooting of issues, as well as a resource for the business development team during review of potential new product candidates.
Duties and responsibilities:
Provides strategic leadership, technical expertise, and specialized knowledge for biopharmaceutical formulation development
Identifies analytical science capabilities and technology tools needed to enable formulation development, qc testing, deviation investigation and new drug candidate formulation development
Applies scientific thinking to the design of sound, well understood, and robust experimental plan to support new formulations and manufacturing troubleshooting
Reviews and interprets data and reports associated with stability testing and other characterization testing of new drug products and formulations
Provides technical input and oversight related to formulations used and/or prepared by cmos and contracting testing laboratories, including the review and approval of test records, forms, methods, protocols and reports for nonclinical and clinical studies
Prepares technical reports, formulation development reports and related documents to support regulatory submissions
Serves as sme for areas of responsibility during regulatory inspections
Provides support and contributes to development, pharmaceutical sciences and cross-function activities as needed
Qualifications:
Bachelors or phd in chemistry, chemical engineering, pharmaceutical development or other relevant scientific discipline
With phd - 10+ years in the industrial biopharmaceutical formulation development field
With bachelors - 15+ years in the industrial biopharmaceutical formulation development field
Experience in pharmaceutical development of peptides and proteins is required
Experience:
Experience with managing internal and contract labs for pre-formulation and formulation development and testing
Hands-on experience with formulation development
Comprehensive working knowledge of good manufacturing practices (cgmps) and regulatory guidance documents as they relate to quality testing of pharmaceutical products
Ability to establish and maintain effective working relationships
Ability to effectively prioritize and deliver on tight timelines
Outstanding problem solving abilities
Ability to recognize the potential of new technologies to meet analytical or qc testing requirements.
Detail-oriented, with good organizational and project management skills
Good oral and written communications skills
Proficient with ms word, powerpoint, excel
Beginning july 19, 2021, coherus biosciences requires all new hires to be fully vaccinated against covid-19 as of their start dateThis requirement is a condition of employment at coherus biosciences, and it applies regardless of whether the position is located at a coherus biosciences facility or is fully remoteIf you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
Job type: full-time
Work location: multiple locations
