Pace® Life Sciences provides a full suite of contract CMC development, CTM manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries from our network of CDMO sites, GMP analytical testing laboratories, and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We share a common goal to bring real value to people, healthcare professionals, and health businesses worldwide. Driven by our commitment to improving our health, we deliver services that offer hope and a better, safer, healthier life for everyone.

Summary:

The Biopharmaceutical Group Leader is responsible for the day-to-day management of the biopharmaceutical lab operation and team for the Pace® Life Sciences Division. They plan, coordinate, and direct the operations of the biopharmaceutical group to meet client timelines, provide data of appropriate quality, and deliver analytical reports and protocols on time. They are responsible for assuring that individuals operate within the GMP quality system and drive individual productivity.

NOTE: Relocation assistance may be provided for this position.

Essential Duties and Responsibilities include the following but are not limited to:

• 
  Ensure employees are properly trained and qualified for their positions in a GMP environment
• Evaluate employee performance. Write, approve, administer, and participate in yearly performance reviews
• Assist in equipment and facility maintenance; investigate and facilitate the solving of any equipment/ facility problems
• Facilitate the resolution of employee issues, problems, confrontations, and complaints

Project Management:

• 
  Biopharmaceutical Group Leaders are responsible for client interactions
• Biopharmaceutical Group Leaders also ensure that status and progress updates are presented to Pace® Life Sciences management and the client as necessary
• Coordinate workflow, from incoming samples through analysis to outgoing results
• Responsible for clearly documenting client requirements within the appropriate format (e.g., Deviations, Project Logs, and Project Requirements)

Technical Responsibilities:

• Group Leaders possess thorough technical and quality understanding within their specialized area and can provide basic technical and quality support to staff members and clients. (ELISA, PCR, and Liquid Chromatography, HPLC)
• Provide technical guidance to staff on a day-to-day basis in order to build staff skills and positively affect production flow.
• Develop and maintain computer skills related to work performed.
  Oversee work, ensure technical accuracy, and assist with validation tasks (as appropriate)
• Participate in management and technical meetings with PLS management and/or the client to ensure PLS and client goals are known, addressed, and satisfied.

Group Management:

• Continually assess the production capacity of the group relative to others in the group to ensure that the appropriate steps are being taken to attain the highest possible level of productivity.
• Set production goals for all the individuals within the group. Make sure that capacity is understood by each individual, as appropriate, to ensure that client expectations are set accurately.
• Assign training, laboratory, and facility duties. Monitor and review these activities to ensure they are properly conducted and completed promptly.
• Interview and assist in selecting new personnel and recommending and promoting current personnel.

Quality/Regulatory Oversight:

• Ensure that the technical area complies with Pace Analytical Life Sciences and general regulatory requirements. Work closely with the Quality Assurance group to ensure all quality procedures are followed and enforced.
• Become familiar and regularly updated with quality and regulatory policies associated with the technical area.
• Ensure office, laboratory, and utility areas are clean and orderly so that quality work may be carried out safely and efficiently.
• Participate in writing, reviewing, and approving SOPs, calibration procedures, laboratory procedures, validation protocols, maintenance procedures, and any other necessary protocols or reports as appropriate.
• Participate in, promote, and ensure that all employees participate in quality, cGMP, safety, method, and technique training appropriate for their area and that all employees follow these instructions in their daily work.

Supervisory Responsibilities:

Directly supervises employees in their assigned group. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibility includes interviewing, hiring, and training employees. Planning, assigning, and directing work. Appraising performance, rewarding and disciplining employees, addressing complaints, and resolving problems.

Equipment Issued
Laptop computer package.

Travel
<10 %

Driving Requirements
Need to have a valid driver's license.

Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the required knowledge, skill, and/or ability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• 5 years of experience within the biopharmaceutical field. Previous experience managing, supervising and/or leading a group.
• Bachelor's degree in a scientific discipline, Biochemistry or Biology preferred
• Experience with techniques such as ELISA, PCR, and HPLC

Physical/Mental Requirements:

The physical demands described herein are representative of those that an employee must meet to perform the essential functions of the job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Mobility to work in a lab and office setting, use standard office and lab equipment and standing or sitting for extended periods; exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.

Working Environment:

Work is performed in a lab and office setting. Work is subject to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.

OFCCP Statement:

Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veteran, individuals with disabilities, sexual orientation, or gender identity.