Rocket Pharma is seeking a high energy, motivated candidate for Manufacturing Associate (level to be determined based on level of experience). Candidate will join a well-funded (public, NASDAQ: RCKT) clinical-stage LVV and AAV gene therapy company (biologics) with a broad pipeline in multiple pediatric rare disease clinical indications in US & EU. RCKT was one of the top performing biotech stocks in 2018.
This technical position is a key role in manufacturing operations. The ideal candidate will have relevant industry experience in pharma, biotechnology, cell, gene or regenerative medicine; or similar cGMP clinical or commercial manufacturing experience at a leading pharma or biotech organization.
As a Manufacturing Associate, you will be responsible for manufacture of viral vector therapies. Additional responsibilities include set-up, operation and cleaning of equipment, equipment and process monitoring, upkeep of cGMP equipment and manufacturing area, completing and reviewing batch documentation, coordinating material requirements and performing functions supporting cGMP manufacture of viral vector therapies.
The ideal candidate will also have a strong passion and curiosity for science and gene therapy with the desire to bring needed cures from bench to bedside. Demonstrated genuine interest and curiosity in research and process development highly valued.
- Perform all upstream and downstream unit operations required to manufacture viral vector therapies including; cell line initiation (vial thaw), cell line scale-up, bioreactor operations, transfection, harvest clarification, TFF, chromatography and bulk drug substance fill;
- Perform all activities using industry standard aseptic techniques, and following accepted cleanroom behaviors and controls (i.e., gowning, flows; sanitization, segregation);
- Collaborate with Logistics, Maintenance, Metrology, EM, and QA teams as “customers” during manufacturing process;
- Assist Management with process technical transfer, or with the implementation of cGMP facility and equipment continuous improvements;
- Maintain cGMP equipment and manufacturing areas in a safe and compliant readiness state; observes and follows all safety, regulatory and compliance requirements;
- Able to operate and maintain all primary and ancillary cGMP equipment;
- Assist with the establishment of cGMP systems and documents;
- Identify and suggest/implement solutions in a timely manner as part of continuous improvement;
- Authors, revises, follows and maintains Standard Operating Procedures;
- Authors, follows, completes and reviews all cGMP batch documentation including Batch Records, Forms, equipment printouts, Sample Requests and Test Results;
- Collaborate with others from diverse backgrounds in order to identify problems and find solutions;
- Perform internal safety and quality inspections and audits;
- Train others as required
Education/Experience and Skill Requirements
- Previous work experience in Pharma/biologics Manufacturing; (position level dependent upon candidate experience);
- Direct experience operating and maintaining upstream and downstream process equipment such as stirred bioreactor, depth filtration system, TFF system, chromatography system, tubing welder / sealer, filter integrity tester, reach-in incubator, BSC and automated cell counter;
- Experience with animal cell culture techniques and principles from shake flask to 2,000L bioreactor scale;
- Demonstrated ability to accurately complete, compile and review cGMP batch documentation per cGDP requirements;
- Must have experience with GMP/regulated manufacturing environments and materials;
- Working knowledge of cGMP facility and utility validation; prior experience executing equipment FAT, SAT, IQ/OQ/PQ is highly desirable;
- Hands on experience with material, document and Quality Management System software (such as ERP, LIMS, TrackWise, and/or MasterControl solutions);
- Ability to work under direct supervision and complete tasks with attention to detail and right-first-time mind set;
- Sense of ownership and pride in your performance and its impact on company’s success;
- Critical thinker and problem-solving skills;
- Team player;
- Good time-management skills;
- Great interpersonal and communication skills;
- B.S. or equivalent in Life Science, Biotechnology, ChemE, or similar relevant field;
- Location: Cranbury, NJ
A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.
About Rocket Pharma
Rocket Pharma is bringing hope and relief to patients with undertreated rare diseases through establishing a sustainable, integrated, multi-platform curative gene therapy company. We are searching for hands-on team players that enjoy working in extremely collaborative working environments with colleagues that share an excitement for developing innovative technology to treat unmet medical needs. www.rocketpharma.com.
Interested in joining our team? Contact us today!
Resumes with cover letters may be submitted to firstname.lastname@example.org