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18 days old

LogisticsManager (Biopharmaceutical) Thousand Oaks, CA

Kelly Services
Thousand Oaks, CA 91358
**Logistics Manager (Biopharmaceutical) Thousand Oaks, CA** (Remote during COVID restrictions)



We are seeking an energetic, highly motivated and creative manager with experience in transfer processes to CMO partners and serving as CMO liaison during manufacturing campaigns. In particular, we are seeking individuals with experience in management of fill/finish operations for sterile parenteral drug products. The ideal candidate is a strong team player who has outstanding written and oral communication skills and the ability to communicate and collaborate in an interdisciplinary environment.



**Responsibilities:**




+ Actively manage the outsourced development and GMP manufacturing of parenteral drug products by CMOs. The primary focus of this role covers operations and logistics associated with parenteral fill/finish operations, clinical packaging and distribution. Monitoring of operational quality is a critical part of this role.

+ Assistance in management of Drug Substance CMOs may be assigned as well

+ Effectively negotiate Confidentiality Agreements, Master Services Agreements and Work Orders

+ Prepare, review and negotiate request for proposals

+ Work with company Business Operations to manage requisitions and financial matters associated with CMO operations

+ Monitor and verify implementation of company controlled documents at CMOs

+ Write, revise and review Standard Operating Procedures

+ Assist in development of budgets and accurately report accruals to Business Operations

+ Support business reviews with CMOs and external partners

+ Effectively communicate issues to management and project teams

+ Organize and participate in teleconferences and (when Covid-19 restrictions can be lifted) face-to-face meetings with CMOs; work closely with teams to manage deliverables

+ Maintain outsourced project timelines and ensure progress against established dates

+ Onboard CMOs including integration into business systems

+ Maintain oversight of budgets and project deliverables associated with outsourced development, testing and manufacturing activities

+ Communicate issues and project changes and facilitate timely discussion and resolution

+ Strong negotiation, verbal and written communication skills

+ Ability to manage multiple programs/projects; sound organizational and time management skills



**Requirements:**




+ 5+ years management experience in a biotech organization or relevant manufacturing environment and a BA or BS degree; MA, MS, PhD degrees may be considered.

+ Prior experience in outsourced development and manufacturing is required

+ Experience in parenteral products manufacture, is expected, experience with drug substance manufacturing is highly desired

+ Strong computer skills and experience project management software

+ Good understanding of activities related to the CMC development, with strong focus on Quality expectations of cGMP operations

+ Knowledge of GMPs and associated regulations including experience reviewing master and executed batch records, specifications, and certificates of analysis.

+ Strong communication skills, good problem-solving abilities, and an ability to work effectively in a dynamic environment with a diverse team of co-workers



**For immediate consideration, apply today! Contact Toni at 714 454 8252 OR TONM369@kellyservices.com**




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-01-08 Expires: 2021-02-25

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LogisticsManager (Biopharmaceutical) Thousand Oaks, CA

Kelly Services
Thousand Oaks, CA 91358

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