Kelly Scientific Resources
Project Manager - Scientific
|Post Date:||Jan 03, 2018||Type:||Full-Time|
|Start Date:||1/3/2018||Salary:|| |
Project Manager (PM) I Pharmaceutical / Biologics, San Diego, CA
Job Summary: The Project Manager (PM) is responsible for the coordination and proactive management of ongoing active pharmaceutical ingredient manufacturing campaigns for our customers in the biotechnology and pharmaceutical industries. The PM reports in to the Senior Project Manager, and liaises externally with the customers as well as internally with company Sales and site-specific Operations (QC, QA, Logistics, and Production) teams to ensure that the clients' 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 (Torrance, CA and Bubendorf, Switzerland) 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.
- Bachelor's degree (B.S) in Science (Chemistry, Biochemistry, Biology or similar) field
- Three (3) to five (5) years pharm/biotech experience
- One (1) to three (3) years of project management experience
- One (1) to two (2) years in customer-facing role, such as Sales, consulting, or Project Management in the pharma, biotech or medical device industry
- Ability to understand financial aspects of customer accounts (Payment terms, pre-payment requirements, forecasting)
- Excellent computer skills, especially MS Office, CRM (Salesforce), Master Control, Document-sharing (SharePoint, ShareFile), ERP (SAP, Lawson M3), Online and video-conferencing meetings (WebEx); MS Project
- Excellent written and oral communication skills
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one¿s time
- Communicate effectively and ability to function well in a team environment
- Must be able to lift up to 25 lbs.
- PMP certification
- One (1) to three (3) years laboratory, laboratory-related, and/or cGMP laboratory experience
- Peptide, small molecule, oligonucleotide, or recombinant protein manufacturing experience
- FDA and/or Global Regulatory and compliance experience
- CMO or CRO experience
- Knowledge of Chemistry, Manufacturing, and Controls (CMC) documents having to do with IND and NDA filings
- Knowledge of packaging and shipping of drug substances domestically and/or internationally
- Familiarity with drug substance characterization analysis (HPLC, UPLC, LC-MS, MS, GC-MS, AAA, CHN)
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 relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
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 2016 was $5.3 billion. Visit kellyservices.com and connect with 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 is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
Kelly Scientific Resources
Name: Carl Graves
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