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Full-time
high school
Posted 4d ago
~40 hrs/week
Responsibilities
The Production Room Leader oversees clinical packaging, labeling, and manufacturing operations while ensuring compliance with cGMP regulations and SOPs. They are also responsible for training packaging technicians and maintaining the cleanliness and safety of the production area.
Requirements
Candidates must have a high school diploma or GED and at least one year of experience in clinical supplies packaging or cGMP environments. Strong communication skills and the ability to supervise operations and meet critical timelines are essential.
Full job description
The Clinical Supplies Room Leader, acting under direct supervision, executes and oversees all phases of clinical packaging, labeling, manufacturing, and assembly of investigational drug product that includes but is not limited to blistering, bottling, carding, encapsulation, manufacturing, labeling, and assembly. He/She prepares and completes packaging supplies and required documentation in accordance with approved manufacturing instructions (MI’s), company SOP’s and cGMP Regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Execute packaging of clinical supplies as determined by the approved manufacturing instructions (MI’s) in accordance with company SOP’s and cGMP Regulations.
Complete support documentation associated with the execution of the packaging operation(s) being performed.
Ensure that packaging areas are maintained in accordance with company SOP’s and cGMP Regulations before, during, and after any packaging operation.
Able to operate packaging equipment.
Train Clinical Supplies Packaging Technicians on job specific duties.
Monitor Clinical Supplies Packaging Technicians in assigned packaging area to ensure compliance with company SOP’s, manufacturing instructions (MI’s), and cGMP Regulations.
Adhere to set safety standards.
Participate actively in regular meetings.
Achieve expected performance measures.
Other duties as assigned.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
High School diploma or general education degree (GED) equivalent
1+ years of previous clinical supplies packaging or cGMP experience required.
Excellent oral and written communication skills to communicate with the team, peers, management, and external contacts.
Demonstrated ability to monitor and supervise packaging operations.
Demonstrate the ability to lead as a change agent, handle multiple tasks simultaneously, and negotiate and meet critical timelines.
Responsible for cleaning of cGMP packaging areas, equipment and utensils on an as needed basis.
A specialist CDMO delivering commercial packaging, clinical trial and sterile manufacturing services
Industry
Pharmaceutical Manufacturing
Company size
1,001-5,000 employees
Headquarters
Allentown, PA
LinkedIn followers
17,704
Total funding
$713M
Sharp helps pharmaceutical and biotech companies bring therapies to patients worldwide. As a specialist CDMO, we provide commercial packaging, clinical trial, and sterile manufacturing services. For more than 70 years, we have helped clients navigate complexity across the product lifecycle—from pre-clinical development through commercial launch and beyond. With facilities in the United States, United Kingdom, Belgium, and the Netherlands, and a global network of more than 30 clinical depots, we support our clients with the precision, quality and reliability they can lean on.
We’re a team of 2,500+ united by our common purpose which is to help make lives better. Sharp consistently invests in the global capacity our clients need to innovate, evolve, and deliver. So, their therapies reach the patients who need them.
Offices: 7451 Keebler Way, Allentown, PA 18106, US · Unit 28, Heol Klockner, Heads of the Valleys Ind Est, Rhymney, Wales NP225RL , GB · 23 Carland Rd, Conshohocken, Pennsylvania 19428, US · 2400 Baglyos Circle, Bethlehem Township, Pennsylvania 18020, US · Klöcknerstraat 1 b, Hamont, Flemish Region 3930, BE