CMC Analytical Scientist, Biologics CMC Analytical Development

Location
San Francisco, CA, United States
Posted
Feb 09, 2021
Ref
1008
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
CMC ANALYTICAL SCIENTIST, BIOLOGICS CMC ANALYTICAL DEVELOPMENT

Position Summary:

The CMC Analytical Scientist (Chemist/Biochemist) will support the GBT biologics Drug Substance and Drug Product GMP analytical testing. The candidate will be responsible for analytical testing support and documentation as required by GBT SOPs and regulatory guidance. The candidate will also be responsible to review and verify process and CMC analytical data from CMOs for critical GMP/regulatory documents. The candidate will also provide support to organize and archive the completed internal and external analytical CMC documents. The candidate may perform other duties to support GBT biologics CMC development and manufacturing as appropriate.

Essential Duties and Responsibilities:

  • Perform a variety of analytical assays as the large molecule analytical development expert on purity biologics assays, test method development and qualification. The main analytical methods this role is responsible for are: SEC, CE, cIEF, LCMS, Biacore
  • Collaborate with the internal and external partners to design and execute analytical studies to enable clinical, process development, and stability programs
  • Support Quality, Regulatory Affairs and CMC team by facilitating author, review, remediate relevant CMC section in regulatory filings and address agency questions
  • Support internal lab analytical development activities and manage method technical transfers to CTL and CMO


Qualifications:

  • A degree Biochemistry, Chemistry, Chemical engineering or related discipline. PhD with minimum 1 years of experience, MS with 4-5 years, BS with 7+ years
  • Must have hands-on experience in analytical method development and biologics product characterization (must have chromatography experience (HPLC/UPLC/CE), Biacore, LCMS highly desirable
  • In-depth experience and knowledge in large molecule analytics
  • Must have experience in other CMC functional areas: Cell Culture, API Purification, Drug Product
  • Broad knowledge of the biopharmaceutical industry, including in-depth operating knowledge of the processes and functions involved in biologics drug development and comparability assessment
  • Oversee the characterization and inventory of critical reagents used in analytical assays
  • Significant protein characterization experience with HPLC, UPLC, Biacore, LCMS, CE as well as technical knowledge of associated method controls, software and instruments (Empower, Chemstation, Masshunter, Agilent, Waters, etc.)
  • Highly desirable to have experience with automation systems (TECAN, Caliper, Perkin Elmer, Agilent Bravo)
  • Experience in recombinant protein submissions is desirable. Working knowledge of BLA submissions, Quality and regulatory requirements
  • Must have excellent problem-solving skills and verbal and written communication skills
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with highly performing colleagues
  • Comfortable executing on multiple projects independently, adaptable and a team-player
  • Highly collaborative with excellent interpersonal, verbal and written 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.

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.