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Manager, Upstream Manufacturing, San Diego, CAJob Duties and Responsibilities:
Leads, mentors, and trains all manufacturing employees in execution of production activities, serves as a role model and provides career development and direction.
Responsible for specific product-related operations in cell culture / fermentation. Functions as a Subject Matter Expert for manufacturing.
Responsible for specifically assigned projects, to include monitoring project timelines, ordering supplies, and communication of project status to Scientific / Manufacturing senior management.
Responsible for all activities involving aseptic techniques and maintains production equipment with single-use materials as it relates to cell culture (Stir-Tank bioreactors, Wave bioreactors, incubators, shakers, and cell separation equipment).
Provides detailed observations, analyzes data and interprets results. Communicates these results to others.
Initiates deviations, assesses product quality impact, and proposes and executes Corrective and Preventative Actions (CAPA).
Reviews and approves SOPs, master batch records, and other cGMP documentation. Prepares technical reports, summaries, protocols, batch records, and quantitative analyses as needed.
Change owner for implementation or revision of equipment, documentation, and material specifications.
Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
Supports multiple projects simultaneously.
Proposes implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
Develops effective working relationships with both internal and external partners.
Represents departmental activities as needed, including project teams, task forces, audits, and business or technical meetings with outside groups.
Assists coordinating with downstream operations.
Provide input and feedback on performance of production associates and lab technicians.
May cross-train on various tasks including Downstream cGMP manufacturing and R&D processes as needed to support overall success of the Biologics group.
General Responsibilities:
Operates to the highest ethical and moral standards.
Complies with company's policies and procedures.
Adheres to quality standards set by regulations and company policies, procedures, and mission.
Communicates effectively with Supervisors, colleagues, and subordinates.
Ability to participate effectively as a team player in all aspects of company's business.
Travel as needed to attend professional conferences and train on new technologies.
Job Requirements:
Bachelor's degree (BA / BS) or Master's degree (MA / MS) that included laboratory work in Biology, Microbiology, Chemical Engineering, or related field.
Minimum of five (5) years of experience with Master's degree (MA / MS), or minimum of eight (8) years of experience as an Upstream / Production Associate, or equivalent experience in a manufacturing environment with a Bachelor's degree (BA / BS).
Supervisory role experience is a must.
Knowledge of mammalian cell culture for production of biopharmaceuticals.
Skill with aseptic technique, bioreactor operation, and single-use technologies following SOPs, batch records, and working within a cGMP regulated environment.
Demonstrated ability to observe technical issues and directs trouble-shooting of process and equipment problems.
Ability to organize workload, oversee workload of direct reports, and relevant resource requirements.
Skill in leadership duties to include time-management and planning.
Ability to successfully perform multiple tasks, when required.
Ability to safely operate production equipment in accordance with established procedures.
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 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 9,000 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.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 kellyservices.com and connect with us on Facebook at https://www.facebook.com/kellyservices , LinkedIn at http://www.linkedin.com/company/kellyservices and Twitter at https://twitter.com/kellyservices .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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
