Associate Director, CMC Analytical
ASSOCIATE DIRECTOR, CMC ANALYTICAL
This Associate Director role will manage a group of analytical staff and represent analytical on CMC teams. Hands-on management and problem-solving skills, motivation to own and complete deliverables, effective communication and collaboration skills, and strong technical competency are essential. This role includes both office- and laboratory-based opportunities, including management of in-house testing in GBT’s R&D analytical laboratory and outsourced cGMP testing at CMO/CRO partners. This role will report into the Head of CMC Analytical.
GBT places a high value on cooperative team dynamics and a positive, “can-do” work ethic. The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication and interpersonal skills are needed.
Essential Duties and Responsibilities:
- Group leader, including management and professional development responsibilities for direct reports
- Analytical lead on late-stage research and/or development project(s), including representing analytical function on CMC teams and independence in technical decision making and timeline commitments
- Author CMC sections for US and ex-US regulatory filings (IND/IMPD, NDA/MAA) and responses to regulatory authority queries
- Critically interpret and effectively present data
- Oversee method development/validation/transfer
- Manage in-house and outsourced (CMO/CRO) analytical activities supporting drug substance and drug product development
- Author technical protocols and reports
- Propose specifications for drug substance and drug product manufacturing
- Critically review and approve analytical data and documentation, including driving OOS/OOT investigations
- Collaborate effectively with colleagues in pharmaceutical development, chemical development, quality and regulatory
- Hands-on presence in laboratory to work with analytical staff as needed, with potential to perform some non-routine testing if required
- Manage or participate in department infrastructure and process improvement initiatives
- Degree in chemistry or related discipline with 7+ years of relevant industrial experience and 3+ years of experience leading teams and/or managing people
- Master’s or Doctoral degree preferred
- Some prior experience in impurity characterization by mass spectrometry is desirable
- Familiar with current analytical techniques used for pharmaceutical analysis
- Thorough understanding of cGMPs, ICH guidelines, industry best practices and compendia
- Detail oriented with excellent written and oral communication skills
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
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.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.