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1+ months

Manufacturing Lead

Kelly Services
San Diego, CA 92108
**Kelly Services is actively recruiting for a Direct Hire opportunity in San Diego, CA for a Manufacturing Manager.**



This Manufacturing Manager role is for a small privately-held, clinical stage biopharmaceutical company that has developed a proprietary oncolytic virus for cancer therapy. In preparation for phase III clinical studies, commercial readiness, and licensing, the company has recently completed the construction of a small BSL-2 cGMP manufacturing facility, complete with upstream, downstream and filling areas. The company is looking for a motivated, skilled individual to work with the team and bring the facility to a fully compliant operation.


ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned.

Participate in the startup of a new manufacturing facility and operation

Author SOPs spanning all areas of cGMP manufacturing operations.

Write and execute validation protocols (IQ, OQ, PQ, PV) and write the associated reports

Participate in cross-functional team meetings to assist with delivering a robust, quality, sterile product.

Participate in vendor meetings on facility construction, qualification, and maintenance.

Perform manufacturing operations according to cGMP

Perform aseptic processing including cell culture, operating cell culture bioreactors, TFF for drug substance manufacturing, filling, capping, inspection and labeling of drug product

Perform aseptic process facility qualification and testing to ensure sterile product is produced

Maintain the operation in a state of compliance

Manage and perform supply chain activities such as materials ordering, receiving, testing, release, shipping and inventory management

Perform equipment maintenance and calibration

Manage environmental monitoring programs

Manage facility permitting and licensing by local authorities

Manage facility maintenance, upkeep and cleaning activities


QUALIFICATIONS

Required:

BS/BA in a Life-Science or Chemistry related discipline or relevant experience

Ability to communicate effectively in writing and verbally.

3+ years in a cGMP clean room manufacturing setting in the biotech arena with hands on experience in mammalian cell culture and downstream processes; aseptic processing techniques a plus.


Must have clean room manufacturing experience

Demonstrated ability to write SOPs.

Understanding and compliance with good documentation practices

Ability to work in a BSL-2, aseptic environment.

Self-motivated, independent, able to work with minimal supervision.

Enjoys wearing multiple hats and creating a new process to help treat cancer.

Preferred:

Experience with hazardous materials management

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk, use hands and talk or hear. The employee is frequently required to reach with hands and arms. The employee is frequently required to walk, and occasionally stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.


**APPLY NOW!**


\#TJP2022_SPEC


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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 (plus, did we mention we provide a ton of benefits ?). 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: 2022-06-08 Expires: 2022-08-20

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Manufacturing Lead

Kelly Services
San Diego, CA 92108

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