Exel

Exel

Senior Commercial Drug Substance Manufacturing Manager

Alameda, CA · Senior

Sponsorship not specified$151k-$214kDetected 28 days ago
Data AnalysisExcelLogisticsProcess ImprovementGMPCommunicationCollaboration

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61Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 3 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

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About the role

  • SUMMARY/JOB PURPOSE: This role is responsible for supporting Exelixis' small molecule drug substance commercial and clinical manufacturing pipeline.
  • SUPERVISORY RESPONSIBILITIES: - The role has no direct supervisory responsibilities; however, the candidate is expected to provide direction to CMOs, consultants, or 3 rd parties.
  • The base pay range for this position is $151,000 - $214,000 annually.

Responsibilities

  • Support Exelixis' Active Pharmaceutical Ingredient (API) and raw materials third-party manufacturers and test labs for Exelixis commercial drug substance ensuring strong technical oversight.
  • Lead onboarding and qualification of new raw materials suppliers.
  • Lead and plan business review meetings with the CMOs tracking the manufacturing and quality performance of our products at the CMO
  • Partner effectively with the quality organization to provide third-party oversight of commercial API manufacturing operations to deliver API that meets cGMP quality and compliance standards.
  • As point of contact oversee, track, and manage active pharmaceutical ingredient (API) and raw material third-party manufacturers and test labs for Exelixis commercial drug substance to ensure adherence to Exelixis requirements.
  • Responsible for the timely review and approval of batch documents for drug substance manufacturing ensuring they meet the technical and regulatory requirements.
  • Specifically, the role guides and oversees our CMO partners in process changes/optimizations, process qualifications, process validations and commercial production.
  • This role also leads change projects, raw materials qualifications, internal investigations, deviations support, technology transfers, scale-up as needed, and supports the transition of projects from development to commercial.

Requirements

  • BS/BA degree in organic chemistry, chemical engineering, or related discipline and a minimum of nine years of related experience
  • MS/MA degree in a related discipline and a minimum of seven years of related experience
  • Travel required - 30% of domestic travel required
  • It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
  • Preparation and writing of key sections of regulatory documents (such as NDAs, MAAs, and INDs) may be required.

Nice to have

  • A minimum of twelve years of experience in a cGMP pharmaceutical/biotech manufacturing environment
  • A minimum of eight years of experience in commercial small molecule active pharmaceutical ingredients manufacturing operations
  • A minimum of two years of experience managing Contract Manufacturing Organizations preferred
  • Track record of working with external contract organizations (CMOs) in a manufacturing role and a thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing is a must.
  • Experience in working with contract manufacturing organizations (CMOs) in North America, EU, and Asia, including raw materials and Drug Substances is also highly desired.
  • The successful individual will have proven organic chemistry or chemical engineering skills with demonstrated expertise in process optimization, troubleshooting, change, and deviation management.
  • Experience in performing technology transfer of processes.
  • Experience in process development, process characterization, and process validation.

Skills

  • Strong Knowledge of regulatory and compliance issues as they pertain to the commercial manufacture of Drug Substances.
  • Good technical knowledge in raw materials and drug substance manufacturing.
  • Excellent data analysis skills and experience with a variety of scientific software applications.
  • Has flexibility to accommodate to fast-paced work environment and deadlines.
  • Strong and effective interpersonal skills, a fast-paced company.
  • Ability to communicate clearly and concisely verbally and in writing.
  • Applies strong analytical and business communication skills.
  • Excellent verbal and written communication skills.
  • Must be proficient in Word, Excel and PowerPoint.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Education/Experience:

Compensation

  • The base pay range for this position is $151,000 - $214,000 annually.
  • The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.

Benefits

  • The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
  • Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.

Company info

  • Is part of a team that oversees the technical and operational performance of our DS processes at our CMOs as principal point of contact.
  • Work closely with other team members within the department and other functional areas/departments, including logistics, legal, QA, finance, and planning functions to ensure Drug Substance and Raw Materials production is part of a robust supply chain.
  • Perform full executed batch record review for intermediate and API batches as part of the disposition process to support Exelixis batch disposition targets.
  • Is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) manufacturing.
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