- Meet client process demands through planning, scheduling, manufacture and delivery.
- of clinical cell therapy products according to established procedures, regulations and contract.
- Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract.
- Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract.
- Ensures process hours are charged - tracked to meet contract and revenue targets.
- Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects.
- Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations
- Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff.
- Ensures a safe work environment for employees.
- Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice.
- Approves job specific curriculum for the training and professional development of department staff.
- Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion.
- Responsible for the profit and loss for the PPU
- Deliver on revenue
- Assures compliance with budget
- Liaison with support groups – supply chain, training, quality systems, and business development
- Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients
- Sets team expectations and goals and delivers the business direction for the PPU
- Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly.
- Coordinates with PPU leadership and team meetings and determines PPU strategy development
- Accountable for driving the spirit of continuous improvement
- Collaborates with Business Development to ensure compliance and contract requirements
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance Investigators
- Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering).
- 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience.
- 5-7 years of leadership experience or equivalent combination of experience.
- Strong business acumen
- Deep understanding of cGMP and cGLP
- Working knowledge of financial operations and budget development
- Relevant IT skills (Visio, Microsoft Project and Excel)
- Ability to think strategically and tactically (detail-oriented)
- Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment
- Analytical and problem-solving skills
- Strong written and oral communication skills
- Meeting management/facilitation skills/teamwork
- Ability to multi-task team is essential
- Flexible and able to adapt to company growth and evolving responsibilities
- Drive to create and maintain order in a fluid technically complex environment
- Integrity, accountability and strong dedication to regulatory compliance
- Continuous improvement mindset
- List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc.
- Must have the ability to work in a team-oriented environment and with clients
- Must be able to work during the weekend, holidays and as required by the company
- May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
- Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
- Must have the ability to work in the cleanroom environment for extended period of time
- Must have the ability to work with specialized equipment
- May work with hazardous materials and chemicals
- Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.
-
Manager Manufacturing Operations
13 hours ago
Lynkx Staffing LLC Saddle Brook, United StatesJob Description · Job Description · Manager Manufacturing Operations Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU ...
-
Associate Director Manufacturing Operations
2 weeks ago
Lynkx Staffing LLC Saddle Brook, United StatesJob Description · Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Ope ...
-
Associate Director Manufacturing Operations
4 weeks ago
Lynkx Staffing LLC Saddle Brook, United StatesJob Description · Job Description · Associate Director, Manufacturing Operations Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturi ...
-
Manufacturing Operator
6 days ago
Knowles Precision Devices New York, United StatesJob Description · Job DescriptionDescriptionWe are seeking highly motivated individuals to join our production team as a manufacturing operator. Manufacturing Operators are responsible for preparing orders for their production line and performing departmental duties while maintai ...
-
Operator, Manufacturing
2 weeks ago
Celularity Florham Park, United StatesJob Description · Job DescriptionDescription:About Celularity · Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatme ...
-
Clinical Manufacturing Operator
4 weeks ago
Clinical Resource Network (CRN) Livingston, United StatesWe are looking for a Clinical Manufacturing Operator for an onsite position in Livingston, New Jersey The Manufacturing Operator will be responsible for daily manufacturing of cell products in support of the company's clinical and commercial platforms. · Responsibilities: · Hand ...
-
Production / Manufacturing Operations
2 weeks ago
Regeneron Pharmaceuticals, Inc Tarrytown, United States Full timeWithin a manufacturing function you will be performing tasks supporting the manufacturing operations of both clinical and commercial manufacturing programs at Regeneron Ireland. · Working a shift pattern in a fully gowned, cleanroom environment, a typical shift might include, but ...
-
VP Manufacturing Operations
2 days ago
The Judge Group Orangeburg, United StatesJudge Direct Placement is seeking a local, degreed, VP of Manufacturing Operations in Orangeburg, NY area The qualified candidate will be responsible for manufacturing operations across multiple facilities. They will work with corporate resources and drive a high-performance cult ...
-
Manufacturing Operations Director
3 weeks ago
KnowHireMatch New York, United StatesWe are actively seeking a Director of Manufacturing Operations to lead our dynamic team in Irvine, focusing on System and Module Manufacturing and Test. This strategic role is centered on managing high-performance electro-optical and opto-mechanical assemblies and laser systems p ...
-
Manufacturing Operations Manager
4 days ago
Vitesse Systems LLC New York, United StatesJob Description · Job Description · Are you ready to take your career to the next level? · Vitesse Systems is your premier source for complex fully integrated, thermal and antenna solutions. Most of all, Vitesse Systems prides itself on the solutions we provide to our customers ...
-
Operator, Tissue Manufacturing
2 weeks ago
Celularity Florham Park, United StatesJob Description · Job DescriptionDescription:About Celularity Inc. · Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the tr ...
-
Clinical Manufacturing Operator
4 days ago
Solomon Page Florham Park, United StatesOur client is looking to fill the role of Clinical Manufacturing Operator - Tissue Manufacturing. This position will be located onsite in the Livingston office. Responsibilities: Responsible for the technical manufacture of company tissue and other products Responsible for the te ...
-
Director of Operations, Aerospace Manufacturing
2 weeks ago
HumanEdge Mahwah, United StatesOpportunity Description · Lead the operations organization and ensure the team meets safety, financial and KPI targets and improve the efficiency and profitability of the organization. Develop the operations capability and organization to meet growth targets. Manage all Manufactu ...
-
Pharmaceuticals Manufacturing Operator
4 weeks ago
Ingenus Fairfield, United StatesJob Description · Job DescriptionIngenus Pharmaceuticals offers a generous Paid Time Off policy, as well as, 14 paid holidays per year. Medical, Dental and Vision benefits are offered to all associates and are effective on the 1st day of the following month after hire. Enrollment ...
-
Manufacturing Production Floor Operator X8
3 weeks ago
Connexion Systems & Engineering, Inc. Moonachie, United StatesJob Description · Job DescriptionOur client is looking for a Manufacturing Production Floor Operator X8 in Moonachie, NJ · Hours: 7-3:30 or 8 - 4:30 · Position Summary: · With supervision, performs basic and routine electronic, mechanical and other required production operations ...
-
Manufacturing Operator
3 weeks ago
Orion Solutions LLC New York, United States**Job Title: Manufacturing Operator** · **Job Type: Full-Time,** · **Non-Exempt/Hourly Professional Work Location: Fall River, MA and Central Islip, NY** · **Work Hours: First Shift: 8 AM - 5 PM (may vary based on business needs)** · **Reports To: Facilities Operations Manager** ...
-
Manufacturing Operator
3 weeks ago
Graver Technologies Newark, United States Full timeGraver Technologies is a U.S. based company serving the industrial filtration, separation and purification needs of companies around the globe. We are located in Glasgow, DE and a member of The Marmon Group (a Berkshire Hathaway Company), an international corporation with more th ...
-
Manufacturing Operator
3 weeks ago
Graver Technologies LLC Newark, United StatesGraver Technologies LLC · Come join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attr ...
-
Manufacturing Operations Engineer
3 weeks ago
Kelly Science, Engineering, Technology & Telecom Mahwah, United StatesManufacturing Operations Engineer · Location: (ONSITE) – Mahwah, New Jersey · Duration: 12+ month contract - (Opportunity for contract extension) · Type: W2 contract (NO C2C OR THIRD PARTY) · Work Authorization - Must be able to work in the U.S. with approved authorization stat ...
-
Manufacturing Operations Director
3 weeks ago
KnowHireMatch New York, United StatesWe are actively seeking a Director of Manufacturing Operations to lead our dynamic team in Irvine, focusing on System and Module Manufacturing and Test. This strategic role is centered on managing high-performance electro-optical and opto-mechanical assemblies and laser systems p ...
Manager Manufacturing Operations - Saddle Brook, United States - Lynkx Staffing LLC
&v=024){kind=logo}
