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1+ months

Senior Process Development 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 Manager-Process Development** 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 for 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, Process Development will be responsible for leading a team of process engineers for the process technology innovation and development strategies of early and late-stage processes. We are seeking a dynamic, motivated individual with process development leadership experience to manage the daily process development activities. The position has accountability for the delivery of a portfolio of projects with direct oversight of multiple program and technology teams that drive rapid development and implementation of new technologies and processes into CMC programs and ensure functional excellence for regulatory strategies for future regulatory applications including INDs and BLAs.


This position will support both Manufacturing and R&D 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.


**Responsibilities:**


Leads a team of process engineers to deliver robust and scalable operations leading to user-friendly cGMP operations and scale-up


Supports technology transfer to clinical and commercial Manufacturing


Manages a team to assess the impact of process parameters on product performance, establish optimal parameters and controls, and execute phase appropriate process characterization experiments


Supervises, mentors, and develops process engineering staff


Oversee process comparability and process validation studies including planning, execution, and documentation management


Supports necessary technical experiments and analysis to enable decisions related to raw materials changes


Prioritizes, develops, and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements


Analyzes data and prepares presentations, data graphs, technical reports, and regulatory documents to support process related decision making and actively engages in scientific and technical discussions to support the decision


Assures completion of daily process development workload. Works with Manufacturing management for the oversight of schedule for team resources


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


Builds effective cross-functional relationships both internally and within the clinical manufacturing team


**Job Requirements**


BS in Chemical/Mechanical/Biological Engineering with 10+ years of experience in engineering roles within a life sciences/biotech organization (with a significant portion of time focused on process engineering specifically) and experience managing engineering professionals (full-time employees and/or contractors/consultants)


8 years in process development and/or GMP environment is preferred.


Understanding of cGMP, FDA, ISO, EMA, and ICH requirements


5+ years in a technical management role


Ability to lead and manage teams including a track record of coaching and mentoring technical talent


Demonstrated success in developing processes for pharmaceutical manufacturing of biotechnology products, aseptic processing, and cell therapy products


Knowledge and experience of process development tools including the use of statistical design of experiments is required. Experience with automation technologies is desired.


Excellent communication and presentation skills and aptitude for problem-solving


Experience with the preparation of regulatory filings for US and external markets


Excellent interpersonal, verbal, and written communication skills are essential


**APPLY NOW FOR IMMEDIATE CONSIDERATION!!**


**\#P2**


**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 Process Development Manager

Kelly Services
Long Island City, NY 11101

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