1+ months

Senior Clinical Manufacturing Manager

Kelly Services
Long Island City, NY 11101
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a **Direct Hire** opportunity to work as a **Senior Clinical Manufacturing Manager** located in **Long Island City, NY** .

**Job Description:** The company is a biologics and bioprinting company with a focus on regenerative medicine that precision manufactures living tissues to allow the replacement of each individual patients parts with tissues designed and created specifically for them. The company has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platforms include a full suite of features to meet the FDAs requirements for therapeutic manufacturing, including novel and proprietary: 3D-bioprinter (GMPrint), bio-ink (ColVivo), and cell processes. In pre-clinical studies, the platform has demonstrated the ability to generate functioning living tissues and the company is currently in clinical Phase 1/2a.

The Senior Manager, Clinical Manufacturing will be responsible for the performance of manufacturing, materials processing, and general testing for development, pilot, and cGMP aseptic manufacturing in accordance with well-defined standards and procedures. We are seeking a dynamic, motivated individual with manufacturing leadership experience to manage the daily manufacture of multiple products in support of the companys clinical-stage and R&D platforms. This individual will be expected to be an active resource for the team on the floor in a generalist capacity and assist in creating a positive work environment. This individual will also provide support to other groups such as Quality Control, Quality Assurance, and Research.

This position will support both Operations and Development and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance.


-Leads a team that consistently produces clinical products while ensuring cGMP compliance through oversight and education of team members

-Develops schedules of workflows to streamline manufacturing processes from initiation to release

-Creates partnerships and systems to produce development and preclinical product to support R&D needs for pipeline projects

-Manages scheduling of lots in coordination with cross-functional groups. Drives resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities

-Assures completion of daily manufacturing workload. Oversight of schedule for team resources

-Leads, investigates and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments

-Stays current with company industry standards, and all applicable regulations.

-Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing

-Oversees cold chain shipping and logistics for incoming tissue and outgoing clinical product

-Lead the receipt of technical transfers from Process Development team, assisting with processing COGs and timelines, and initiating manufacturing suite set-up.

-Receives and manages equipment alarms

-Supports compilation of manufacturing metrics, data, reporting, and process i-improvements.

-Builds effective cross-functional relationships with R&D and Quality and within the clinical manufacturing team

**Job Requirements**

-BS in Chemical/Mechanical/Biological Engineering with 10 years in aseptic in a biopharmaceutical or medical device (preferably in biologics/cell therapies) environment

-8+ years in a cGMP environment with an excellent understanding of federal regulations for Quality Systems (21CFR820) and cGMP manufacturing (21CFR 210,211)

-Aseptic manufacturing of Advanced Technology Medicinal Products experience preferred

-5+ years in a supervisory role and possessing training and scheduling experience

-Proven track record of managing a cGMP facility. Ability to lead and manage teams including experience coaching and mentoring manufacturing staff.

-Strong ethical foundation

-Excellent interpersonal, verbal, and written communication skills are essential



**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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-07-08 Expires: 2022-09-08

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Senior Clinical Manufacturing Manager

Kelly Services
Long Island City, NY 11101

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