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Technical Project Manager (PM) I Pharmaceutical / Biologics, San Diego, CA

Kelly Services

Vista, CA
Job Code:
  • Engineering
Kelly Services
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Job Details

Job Title Technical Project Manager (PM) I Pharmaceutical / Biologics, San Diego, CA

Jobid US15TPAF_BH1444802

Location: Vista, CA, 92085, USA

Description **Live Chat with a Recruiter!!** ****

**Technical Project Manager (PM) I Pharmaceutical / Biologics, San Diego, CA**

**Job Summary:** The Technical Project Manager is responsible for the technical aspects of project coordination and proactively manages operations-related projects. This position liaises with team members in Production, QC, QA, Engineering, Purchasing, Materials Management, Maintenance, and relevant functions to ensure that milestones and deliverables are met.

**Essential Duties and Responsibilities:**

+ Proactively and simultaneously manage multiple (5+) generic and new chemical entity (NCE) drug substance manufacturing projects for non-GMP, clinical and commercial GMP use
+ Ensure that project deliverables and timelines are met as stipulated in customer purchase orders and agreements/contracts (Non-Disclosure Agreement, Master Supply Agreement, Quality Agreement, Developmental Agreement, Statement of Work)
+ Once project is completed, perform closing activities such as shipping, storage, and invoicing of product
+ Interface with project management functions at other company manufacturing sites to track progress of projects ordered within the Americas
+ Consistently communicate timely and project progress updates and/or issues to customers via email and teleconferences
+ Effectively manage customer review, approval and delivery (where applicable) of manufacturing-related documents (batch records, analytical method and validation protocols/reports, CofAs, and release specifications)
+ Facilitate in project-related discussions both internally and externally and generate meeting notes and action items
+ Serve as liaison between customer contacts and technical staff at company manufacturing sites
+ Provide feedback internally on project-related proposal requests as needed
+ Update Enterprise Resource Planning (ERP) and CRM software to reflect real-time project status/requirements
+ Schedule, organize, and document customer visits (technical and quality/audit-related) to manufacturing sites
+ Collaborate with Contract Manager to ensure the feasibility of compliance within all contracts and agreements
+ Maintain close communication with Sales Team to ensure they are kept informed on project interactions with customers
+ Communicate monthly project status, closing, and financials to upper management
+ Participate in sales process whenever needed
+ Assist/train sales force and other key personnel in manufacturing capabilities and associated services
+ Special projects will be assigned on occasion
+ Travel may be required as business demands dictate
+ Occasional trip to the Torrance location may be required
+ Working/Environmental conditions: Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.
**Job Requirements:**

+ Minimum B.S. in Science or Engineering (Chemistry, Chemical Engineering, Biochemistry, Biology or similar fields)
+ 8+ years pharm/biotech experience in a GMP regulated environment
+ 3-5 years of project management experience
+ Process validation / process performance qualification experience
+ Chemistry, Manufacturing, and Controls (CMC) knowledge associated with IND and NDA filings
+ Effective interpersonal and facilitation skills and works well in a team environment
+ Strong organization skills, attention to details, and ability to work in a fast-paced work environment
+ Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
+ Strong problem solving skills and can quickly troubleshoot and implement solutions
+ Excellent computer skills, especially MS Office, MS Project, Master Control, Document-sharing (SharePoint, ShareFile), ERP (SAP), online and video-conferencing meetings (i.e., Skype)
+ Excellent written and oral communication skills
+ Works independently and capable of managing one’s time
**Preferred Experience:**

+ M.S. or Ph.D. in Science or Engineering (Chemistry, Chemical Engineering, Biochemistry, Biology or similar fields)
+ PMP certification
+ Peptide, small molecule, oligonucleotide, or recombinant protein manufacturing experience
+ Laboratory, laboratory-related, and/or cGMP laboratory experience
+ FDA and/or Global Regulatory and compliance experience
+ CMO or CRO experience
**Live Chat with a Recruiter!!** ****

**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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