Senior Manager, Formulations

SENIOR MANAGER, FORMULATIONS

Position Summary:

The Senior Manager, Formulations will conduct Preformulation, formulation development and process development, tech transfer, scale-up, validation and manufacturing activities at Global Blood Therapeutics (GBT) and it's CMO partners.  This position will be a part of the formulation team at GBT and collaborate with other CMC functions to assure robust products are developed for transfer to clinical and commercial manufacture.  This person will conduct hands-on small-scale formulation and processing tests at the GBT lab prior to transferring formula and process to CMOs.

Essential Duties and Responsibilities:

• Perform pre-formulation studies such as physico-chemical characterization, pH solubility, excipient compatibility studies etc. and interpret data
• Design and conduct pre-clinical/toxicology/clinical formulation development activities for various dosage forms
• Support the pharmaceutical development team with clinical phase drug product formulation development, tech transfer to CMO and GMP manufacturing
• Develop strategies to implement changes to processes
• Contribute to and may lead complex projects across functions and interacts effectively with other team members and CMO representatives
• Interact with multiple functional areas both in company and at CMO sites to assure project operations run smoothly and manufacturing issues are addressed
• Contribute to and may lead technical investigations and assessments of deviations
• Oversee and contribute to the completion of all technical and operational activities related to maintaining clinical and commercial product supplies
• Execute statistical design of experiments (DoE) studies to evaluate formulations and process prior to transfer and during scaled production at CMOs
• Lead activities at manufacturing sites, including project timelines, resolving issues, onsite troubleshooting and providing overall technical support.  A hands-on approach to resolving issues on the plant floor is considered necessary for this role
• Define requirements for and review master batch records.  Initiate GBT sourced change controls

Qualifications:

• 6+ years of relevant experience and a BS or BA
• 5+ years of relevant experience and a Ph.D
• In-depth knowledge of Good Manufacturing Practices (GMPs) and a working knowledge of regulatory filing requirements and guidance documents (for example SUPAC)
• Experience with solid dosage formulation development and/or analytical technique is a plus
• In-depth knowledge of solid dosage process equipment and equipment operation is required
• Independent problem-solving and troubleshooting abilities
• Excellent verbal, written, and interpersonal communication skills are required
• Strong computer, organizational and project management skills are required
• This position will require up to 25% travel time (highly variable)

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.