Research Scientist, CMC Analytical
The Research Scientist is a self-motivated, hands-on analytical chemist who will perform and manage in-house testing in our R&D laboratory, as well as manage outsourced GMP analytical activities for small molecule programs. The successful candidate will also participate in in-house infrastructure improvement initiatives. This role includes both office- and laboratory-based responsibilities. 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:
Method development/qualification/transfer for drug substance, drug product and pre-clinical dosing solutions Independently manage in-house and outsourced analytical activities and timelines supporting drug substance and drug product development Exercise sound scientific judgment to propose and execute experimental design relevant to developing methods and reconciling analytical data Independently generate and effectively communicate analytical data in a timely manner Critically review and interpret analytical data and documentation Author technical reports and, as needed, analytical sections of regulatory filings and responses to regulatory authority questions Manage and participate in department infrastructure and process improvement initiatives Collaborate effectively and directly across functions, particularly with colleagues in Chemical Development, Pharmaceutical Development and Quality
Qualifications:
BS/MS in chemistry or at least 8 years related discipline with extensive industrial analytical chemistry experience Familiar with current analytical techniques used for pharmaceutical analysis, especially HPLC, GC and dissolution Prior experience with development of stability-indicating methods, use of MS for impurity/degradant characterization and/or technical writing (reports, regulatory filings, publications) are desirable Understanding of relevant 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 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. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Method development/qualification/transfer for drug substance, drug product and pre-clinical dosing solutions Independently manage in-house and outsourced analytical activities and timelines supporting drug substance and drug product development Exercise sound scientific judgment to propose and execute experimental design relevant to developing methods and reconciling analytical data Independently generate and effectively communicate analytical data in a timely manner Critically review and interpret analytical data and documentation Author technical reports and, as needed, analytical sections of regulatory filings and responses to regulatory authority questions Manage and participate in department infrastructure and process improvement initiatives Collaborate effectively and directly across functions, particularly with colleagues in Chemical Development, Pharmaceutical Development and Quality
Qualifications:
BS/MS in chemistry or at least 8 years related discipline with extensive industrial analytical chemistry experience Familiar with current analytical techniques used for pharmaceutical analysis, especially HPLC, GC and dissolution Prior experience with development of stability-indicating methods, use of MS for impurity/degradant characterization and/or technical writing (reports, regulatory filings, publications) are desirable Understanding of relevant 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 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. 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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