Exel

Exel

Associate Director, Stability Management

Alameda, CA · Director

Sponsorship not specified$172k-$244kDetected 31 days ago
StatisticsGMPCommunicationCollaborationWriting

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odds of building a lasting career here

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

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

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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

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 9 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • SUMMARY/JOB PURPOSE: The Associate Director, Stability Management is responsible for the establishment and management of the stability group withing Exelixis CMC department.
  • This role oversees the overall strategy and oversight of Exelixis' stability and reference standard programs for drug substance, drug product and reference standard for both the commercial and clinical programs.
  • Additional responsibilities include, establishing Exelixis stability policies, procedures, and performance metrics internally and externally with CMOs.

Responsibilities

  • Establish and manage performance metrics
  • Manage and monitor contract laboratory stability testing to ensure adherence to the stability scheduled outlined in the stability protocols.
  • Manage, chair and present in regularly scheduled stability committee meetings.
  • Generate certificate of analysis and retest memos, setting and justifying specifications for both release and stability testing, and regulatory document controls.
  • Manage activities related to drug substance and drug product stability testing, both commercial and clinical:

Requirements

  • BS/BA degree in related discipline and a minimum of eleven years of related experience
  • MS/MA degree in related discipline and a minimum of nine years of related experience
  • PhD degree in related discipline and a minimum of five years of related experience
  • Travel required - 10% of 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.

Nice to have

  • Technical laboratory experience in small molecules and solid oral dosage preferred.
  • Experience in Pharmaceutical industry preferred.

Skills

  • Has extensive experience in relevant industry/profession and area of specialization.
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
  • Has complete understanding and wide application of technical principles, theories, concepts, and techniques.
  • Has good general knowledge of other related disciplines.
  • Applies strong analytical and business communication skills.
  • Education/Experience:
  • BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
  • MS/MA degree in related discipline and a minimum of nine years of related experience; or,
  • PhD degree in related discipline and a minimum of five years of related experience; or,
  • Equivalent combination of education and experience.
  • Experience/The Ideal for Successful Entry into Job:
  • GMP experience preferred

Compensation

  • The base pay range for this position is $172,000 - $244,000 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.
  • Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, and recommends salary increases, promotions, transfers, demotions, or terminations.

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.
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