WHO WE ARE:

At CPL, we are passionate about pharmaceutical product development and contract manufacturing. Our aim is to be the top choice CDMO in the non-sterile liquid and semi-solid pharmaceutical products domain, and ultimately bring benefits to the customers using our manufactured products.

For more than 30 years CPL has partnered with the world’s leading pharmaceutical companies to provide full-service product development and manufacturing, singularly focused on innovation and efficiency.

We recognize our employees are our number one asset and support their career growth. We also offer a benefits program which includes Health/Dental and Vision care, deferred profit-sharing plan, paid time off, employee’s assistance program, work/life balance, employee recognition program, on-site parking, discounted gym membership and wellness program.

Job Summary:

Responsible for establishing and managing the scope, budget, schedule, construction and start-up of various Capital Projects and Continuous Improvement Projects for CPL-, ensuring that all company regulations and procedures are followed and that all work is done in a safe, timely and cost-effective manner. Leads and manages the introduction of new products. Works with key stakeholders to facilitate the implementation of new products and technologies in manufacturing, packaging, and facilities.

Job Summary:

Working in conjunction with Quality Control (QC) Managers, providing scientific and management support to ensure microbiology activities related to testing, investigations, troubleshooting, and scheduling meet all regulatory and customer requirements. Oversee the Environmental Monitoring Program to ensure compliance to requirements. Support Regulatory Inspections, Customer Audits, and Internal Audits as the QC Microbiology Subject Matter Expert.

JOB RESPONSIBILITIES:

• Responsible for overseeing the Microbiology Laboratory by providing direction and leadership to ensure compliance with GMP/cGMPs and ensure current corporate policy guidelines and procedures are implemented for safety, purity, potency and efficacy of drugs.
• Manage the Environmental Monitoring Program from sampling to testing and analysis of test results.
• Author Environmental Monitoring Program trend reports ensuring that all observed trends are assessed and addressed in a timely manner.
• Manage microbiology testing of raw materials, finished products and stability samples.
• Ensure Laboratory activities and resources are coordinated with Commercial Operations, Supply Chain, Production, Product Development, and Quality Assurance to optimize the delivery of results according to stakeholder’s priorities and expectations.
• Participate in regulatory agency inspections, customer audits, and internal audits as the QC Microbiology Subject Matter Expert..
• Lead EM Excursion investigations, ensuring that each event is thoroughly investigated utilizing root cause analysis and and identification and implementation of appropriate corrective actions .
• Direct and coach laboratory personnel responsible for the execution of projects and related tasks to ensure that laboratory work is complete, correct and delivered on time.
• Ensure that departmental performance adheres to established key performance metrics.
• Embraces the concept of Continuous Improvement to optimize laboratory performance.
• Other duties as assigned.

REQUIRED QUALIFICATIONS:

Education:

• Minimum Bachelor of Science Degree in Microbiology

Experience:

• Minimum of 5 years of related hands-on experience in pharmaceutical laboratory environment with a minimum of 2 years of experience in a supervisory role.

Knowledge, Skills, Abilities:

• Strong working knowledge of current GMP/cGMP practices and USP, BP, EP, NF requirements for testing of pharmaceutical materials and products.
• Effective leadership skills with a proven ability to motivate team members and facilitate individual work styles.
• Flexible with the ability to adapt, respond quickly and manage change in a fast-paced environment.
• Excellent communication skills, both verbal and written.
• Ability to work effectively with cross functional teams.
• Ability to meet deadlines and prioritize tasks with strong attention to detail.
• Clear understanding of how the integrity of data is ensured.

PHYSICAL DEMANDS/WORKING CONDITIONS:

• Laboratory work conditions and exposure to chemicals. May require use of protective equipment to reduce personal exposure.
• Flexibility in hours of work to address emergency issues outside of normal workday.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.

We thank all applicants for their expression of interest; however, only those selected for an interview will be contacted. No phone calls or agencies please.