Lead, Tissue Manufacturing
Company: Regional Recreation Corporation of Wood Buffalo
Location: Florham Park
Posted on: February 25, 2021
Celularity Inc. 170 Park Ave Florham Park, NJ 07039 Celularity
is seeking an experienced dynamic individual to lead a motivated
team of clinical operators and manage the daily manufacture of
multiple tissue therapy products in support of the company's
clinical stage platforms. Leveraging Celularity's new,
state-of-the-art cGMP capable facility, this position will make use
of existing innovations and future technologies to meet and exceed
manufacturing demand. Responsibilities
- Lead, mentor and train operators responsible for the technical
manufacture of the company's tissue therapy products. Strong
working knowledge of classified manufacturing environments and
clean room suites. Ability to gown appropriately for clean
room/aseptic manufacturing is required.
- Work cohesively with cross-functional teams in support of
operational efficiency, flexibility, and assurance of timely
completion of all manufactured tissue therapies. Ensure the
delivery of sufficient supply of tissue products for clinical
studies in accordance with company timelines and participate in
clinical supply campaigns.
- Manage daily, routine product manufacturing and related tasks.
Assure completion of daily manufacturing workload. Oversight of
schedule for direct team members.
- Develop and implement technically sound Tissue Manufacturing
batch records, SOPs, protocols, and specifications as required,
while adhering to good documentation practices (GDP).
- Serve as the Subject Matter Expert (SME) and use knowledge of
scientific techniques to troubleshoot processing or product quality
issues with a sense of urgency.
- Ensure overall inspection readiness for area of focus and
participate as an SME in agency inspections.
- Lead the receipt of technical transfers from Process
Development (PD) Team, ensuring appropriate equipment purchase,
assisting with processing COGs and timelines, and initiating
manufacturing suite set-up.
- Lead deviation investigations and support on-time closure of
deviations and CAPAs for areas of focus.
- Provide routine feedback and updates to departmental leadership
on product/process KPIs and participate in the
delivery/communication of established functional strategies to
production team. Qualifications
- BS degree in Biology, Bioengineering or related scientific
- 7+ years' relevant experience with tissue manufacturing,
gowning, and operation within cGMP environments. Understanding of
federal regulations for Quality Systems (21CFR820) and GMP
manufacturing (21CFR 210,211).
- Strong knowledge of GxP regulations (cGTP, cGDP, cGMP)
- Strong organizational and time management skills.
- Ability to work well in a team environment, eager,
- Excellent verbal and written communication skills as well as
strong focus and attention to detail.
- Ability to perform frequent physical tasks with strength and
mobility. Daily tasks call for routine walking and standing in
cleanroom environments and occasional lifting of heavy
- Demonstrated scientific creativity, technical proficiency, and
knowledge of scientific concepts
- Experience in a fast-paced, scientific start-up
- Dynamic individual with the ability to communicate and engage
- Independent and self-starting. Working Conditions
- Position primarily operates for extended periods of time in
classified clean room environments. Daily gowning in company
provided scrubs, PPE and clean room attire.
- Fast paced, start-up environment which may periodically require
work beyond standard business hours.
- Must be able to lift and transport at least 50 pounds
- Handling of potentially biohazardous material (human cells,
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This position is not open to recruiters/staffing agencies.
Unsolicited resumes/CVs submitted to Celularity are not eligible
for a referral fee without a valid written agreement.
Celularity is an Equal Opportunity Employer.
Keywords: Regional Recreation Corporation of Wood Buffalo, New York , Lead, Tissue Manufacturing, Other , Florham Park, New York
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