Rocket Pharma is a company bringing hope and relief to patients with undertreated rare diseases through the development and commercialization of curative first-in-class gene therapies. We are seeking a Manager/Sr. Manager QC Microbiologist with the responsibility to support clinical manufacturing of a range of Gene Therapy products. The incumbent will serve as a subject matter expert for interactions with contract testing laboratories and manufacturing organizations. Technical proficiency in analytical methodology for drug substances and drug products is required for gene based products.
- Establish the EM program for the company’s facility.
- Subject Matter Expert on evaluation of micro-organisms.
- Manage QC-Microbiology activities for lot release and stability testing that are performed internally and externally.
- Assist manufacturing and facility departments to solve microbiology related implementation of new processes.
- Provide management and direction to manufacturing and laboratories on all microbiology activities.
- Review nonconformance’s and ensure that adequate investigation activities are performed and appropriate actions are identified.
- Implement or ensure that corrective action are implemented as appropriate.
- Work with cross functional peers to meet company’s deadlines.
- Author and approve CAPA, OOS, and support deviations at CROs and CMOs.
- Ensure that corrective action are implemented as appropriate.
- Author, revise and review SOPs relevant to QC-Micro and facility operations.
- Review protocols, data summaries, reports for stability studies and validation.
- Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address risks.
- Support manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
- Develop strategy and create metrics to measure effectiveness of strategy.
- Represent QC during regulatory inspections to respond and address microbiology issues and solutions.
- Ensure QC-Micro decisions align with Quality System, GMP and regulatory requirements.
- Assure that all required QC-Micro records (testing, methods, protocols, reports) are generated, approved and managed.
Education/Experience and Skills Requirements:
- MS or BS in Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent.
- 10+ years of relevant experience in Micro-QC or equivalent experience in biotechnology industry.
- Preferred experience with Gene/Cell therapy products for clinical and commercial.
- Experience in compendial and rapid microbial methods by q-PCR for Sterility, Endotoxin, Mycoplasma, Gram Stain.
- Subject Matter Expert on organism evaluations.
- Requires Aseptic experience, +5 years.
- Expertise in microbial method validation.
- Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing.
- Good CMC understanding including setting of product specifications and trending of stability and release data (some statistical background helpful) for cell and gene therapy products.
- Ability to effectively and independently lead the QC-Micro function and engage senior management on Aseptic/microbial issues.
- Expertise in microbial method development and validation.
- Strong analytical skills to troubleshoot and investigate issues from the testing laboratories.
- Strong leadership and project management skills to support a multi-project environment in small biotech or large pharma.
- Ability to interact, cooperate and motivate across departments and functions.
- Effectively works in a fast-paced pharmaceutical environment with prior start-up experience preferred.
- Handle issues appropriately and with a sense of urgency.
- Possesses a positive, can-do attitude and creatively solves problems.
Location: New York, NY / 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.
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Rocket Pharma is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Rocket Pharma via-email, the Internet or directly to hiring managers at Rocket Pharma in any form without a valid written search agreement in place for that position will be deemed the sole property of Rocket Pharma, and no fee will be paid in the event the candidate is hired by Rocket Pharma as a result of the referral or through other means.
*Please note, only qualified applicants that meet the requirements for the position will be contacted. This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.
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