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Description

Playing a leading role and Subject Matter Expert (SME) of Quality Control within PDM Analytical Development & QC department in support of clinical and commercial programs, the position will be mainly responsible for managing QC activities from process validation to commercial manufacture of drug substance (DS), drug product (DP) and final product (FP). The candidate will also participate in post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.

-Coordinate and manage outsourced QC activities of late phase to commercial programs at CDMOs and / or contract testing labs (CTLs), including but not limited to method validation and method transfer

-Author and/or review QC related documents, including methods, protocols, reports and memos

-Perform data review in support of GMP activities for release, in-process, and stability testing as well as method validation and transfer

Additional Skills & Qualifications

Required Skills, Experience and Education:

BS or MS in Chemistry, Pharmaceutical Science or related discipline

6+ years of relevant industrial experience in analytical development/QC with Commercial QC experience is preferred

Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, sampling and testing, stability study, method validation and transfer, etc.

Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills

Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems

Ability to multi-task and thrive in a fast-paced innovative environment

Preferred Skills:

Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills

Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems

Ability to multi-task and thrive in a fast-paced innovative environment

Pay and Benefits

The pay range for this position is $70.00 - $80.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Redwood City,CA.

Application Deadline

This position is anticipated to close on Jun 3, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.