Manager Manufacturing Operations
Company: Lynkx Staffing LLC
Location: Saddle Brook
Posted on: August 7, 2022
Job Description:
Job DescriptionManager 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), Manager, Manufacturing Operations is responsible for
efficient capacity utilization of site resources to meet customer
demand. They will partner with support functions to deliver on
customer demands. This leader is accountable for the management of
client projects at the site and for delivery of results within
project scope, agreed timelines, contract requirements, revenue
targets, as well as compliance and regulatory requirements. The
Manager, Manufacturing Operations is responsible for profit and
loss within their PPU and will deliver on revenue. This role will
also drive individual and team development to ensure a prepared and
empowered workforce to become the provider of choice for the
industry.
- 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 InvestigatorsREQUIREMENTS
- 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. Please note this job description is not
designed to cover or contain a comprehensive listing of activities,
duties, or responsibilities that are required of the employee for
this job. Duties, responsibilities, and activities may change at
any time with or without notice.
Keywords: Lynkx Staffing LLC, Clifton , Manager Manufacturing Operations, Executive , Saddle Brook, New Jersey
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