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Lead Production Operator / Associate Production Manager

Kelly Services

West Chester, PA
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Job Details

Job Title Lead Production Operator / Associate Production Manager

Jobid US41ALRR_BH1427021

Location: West Chester, PA, 19381, USA

Description Kelly Services is currently looking to hire a Lead Production Operator / Associate Production Manager for one of our top Pharma clients in West Chester, PA

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. Must be legally permitted to work in the United States.

**Responsibilities (Lead Operator):**

Lead the execution of all clinical drug product (DP) batches; directly accountable for right first time quality.

Perform all activities supporting the production of sterile DP, including but not limited to: operation of the filling line, formulation of buffers and dilution, preparation of components and supplies including use of the autoclave and part washer, documentation (batch records, logbooks, etc.), routine in-process analytical testing, visual inspection, and batch record review.

Perform front line supervision of shared plant manufacturing resources and DPO product scientists during GMP clinical production.

Provide training on SOP’s, aseptic technique, and activity-based competency assessments.

Author and maintain SOP’s required to support clinical GMP production of sterile DP.

Coordinate calibration and preventive maintenance activities.

Supports Deviation investigations and implementation of CAPA’s.

Supports and executes ongoing validation activities and change controls.

Supports the development of batch records, test protocols, and sampling plans.

Supports operation of a non-GMP development Lab, including reference standards, tox fills, and other early product development studies.

**Additional Responsibilities** (Associate Manager):

Coordinate resource allocation/sharing with BMF upstream, downstream, and media/buffer prep managers.

Work with formulation scientists to facilitate tech transfer of products from the lab into the clinical DP facility.

Mentor less experienced staff on sterile manufacturing operations and GMP; help to build institutional knowledge around sterile fill/finish within written Confirmations and the BMF.

Maintain the DP facility in an “audit ready” state at all times, including facilities and documentation.

Supports technical troubleshooting of the filling line and resolution of atypical events during clinical manufactures.

Develop and maintain Training curriculums.

Supports internal & external audits.

Supports ongoing continuous improvement / risk assessment activities required to operate and maintain the GMP DP facility.

Supports upstream/downstream/cell banking manufacturing operations as-needed.

**Qualifications** (Lead Operator):

Hands-on production experience in aseptic processing and the manufacture of sterile drug products.

Thorough understanding of GMP’s and the regulatory requirements for working in a GMP environment.

Basic understanding of microbiology and HVAC as they relate to the manufacture of sterile drug products.

Excellent planning, verbal and written skills; proficiency in good documentation practices essential.

Highly motivated, dynamic individual, with ability to work both independently and in a team environment, to build productive relationships within and across departments.

Proficient in Microsoft Office Suite of Programs.

BS degree in a related field, or equivalent experience.

**Additional Qualifications** (Associate Manager):

Leadership/supervisory experience in a GMP environment.

Familiarity with the complex technical equipment used in the production of sterile drug products.

Ability to use root cause analysis to develop robust solutions to technical and process manufacturing issues.

Experience in buffer formulation and dilution, equipment troubleshooting & repair, and/or manual visual inspection of parenteral products a plus.

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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