Manufacturing Compliance Manager CAR T

Celgene Corporation Warren , NJ 07059

Posted 12 months ago

Job Description: Req #: 1900813

Location: Warren, New Jersey, United States

Job Category: Technical Development

Work Location: 7 Powder Horn Drive 07059

Organization: Manufacturing

Employee Status: Full-time

Job Type: Regular

Job Summary:

Celgene is seeking a Compliance Manager for Clinical Cellular Therapeutics Manufacturing. The Manager will partner with Manufacturing Leadership and Site Quality to support all aspects of compliance and quality for Manufacturing Operations. This person will be a key leader responsible for GMP operations and meeting critical business goals.

Job Description:

  • Establishes and manages the Celgene Warren Manufacturing Compliance team. This includes: hiring, mentoring and developing exceptional people

  • Championing a culture of exceptional teamwork and communication across the organization

  • Ensuring people have the appropriate level of training

  • Building effective cross-functional relationships

  • Ensuring a culture that embraces the safety of the work environment and the safety of the

patients by compliance with company procedures and policies, and cGMP requirements

  • Establishing department goals, tracking and reporting KPIs, and driving continuous improvement efforts

  • Designing and operating manufacturing systems that are technically sound, promoting effective and efficient operations, and complying with cGMP requirements

  • Owning master batch records for cell therapy processes and ensuring revisions meet compliance and scientific needs

  • Owning and approving routine deviations for the manufacturing department and ensuring on time closure

  • Defining and implementing effective CAPAs to improve compliance and manufacturing success

  • Becoming point of contact in manufacturing for change controls

  • Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients

  • Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports

Basic Qualifications:

  • Bachelors / Masters in relevant science or engineering discipline

  • 8+ years of experience in cGMP biologics manufacturing, experience in Quality Assurance or Regulatory preferred. Further preference given to Cell Therapy experience as well.

  • 2+ years supervising staff in a management role

  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing

  • Demonstrated ability to hire top talent

  • Demonstrated experience building and leading exceptional teams


About Us


At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Brand Manager Pain Category


Posted Yesterday

VIEW JOBS 2/20/2020 12:00:00 AM 2020-05-20T00:00 Site Name: USA - New Jersey - Warren Posted Date: Feb 18 2020 Does the opportunity to manage powerful, well known brands for a global leader in the Consumer Healthcare industry excite you? If so, you owe it to yourself to further explore the opportunity below. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… * Build Brand Equity as measured by annual brand share performance, brand loyalty, and perceived quality. * Drive for competitive advantage by building assets such as patents, trademarks and channel relationships. * Control brand spending within budget. Develop compelling communication that is highly persuasive. * Establish copy strategy and media plan with advertising agency. * Effectively coordinate agency efforts in Advertising Process to create commercial or print media * Makes good commercial decisions to maximize profitability whilst maintaining brand growth and equity strength. * Develops and delivers commercially successful new products that enhance existing brands / categories or create new ones. * Develops and executes integrated communication plans that drive brand growth and equity strength. * Delivers brand consumption targets through optimal marketing mix. * Initiate product, package and labeling development or improvements. * Evaluate, and recommend relevant new and long-term business opportunities. * Uses understanding of current trade climate for competitive advantage. * Selects optimal consumer touch points in the finalization of media plans. * Identifies key brand growth opportunities supported with robust evidence and develops compelling growth recommendations. * Leverages an understanding of the scientific, regulatory and competitive claim environments to help strengthen and grow brand equity. Leverages an understanding of the scientific, regulatory and competitive claim environments to help strengthen and grow brand equity. Why you? Basic Qualifications: * We are looking for professionals with these required skills to achieve our goals: * MBA Degree in Marketing or Related Field * 5+ years of commercial marketing experience (i.e. brand management, market research, consumer behavior, business analysis) including 2 years of CPG specific experience in a Consumer Healthcare environment * Digital Marketing and Analysis Experience * Budgeting and forecasting, commercial and financial acumen Preferred Qualifications: If you have the following characteristics, it would be a plus: * Prior brand management experience in U.S. consumer packaged goods brands, revenue growth management, route-to-market planning and analysis, advertising/media planning, P&L analysis / performance against plan, brand/package contribution, brand portfolio management, and changes in packaging. * Successful managerial experience including associate development and driving results through others. * Demonstrated effectiveness as leader, facilitator, and team member, with strong communication skills. * Proficient in influencing, collaboration, conflict management, and decision making. * Successful experience managing strategic development and execution of advertising campaigns. * Proven ability to develop and apply strategic principles in relation to varied business activities. * Knowledge of multiple product categories as well as with complex regulatory/clinical/medical issues preferred. * Experience with identifying, evaluating and developing new product opportunities. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: * Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk. * Managing individual and team performance. * Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. * Implementing change initiatives and leading change. * Sustaining energy and well-being, building resilience in teams. * Continuously looking for opportunities to learn, build skills and share learning both internally and externally. * Developing people and building a talent pipeline. * Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. * Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site. Glaxosmithkline Warren NJ

Manufacturing Compliance Manager CAR T

Celgene Corporation