Principal Process Engineer

Responsibilities

Conduct laboratory experimentation and analytical testing of putative formulations & drug products, and combination assessment in collaboration with device engineering.

Work on developing processes for lyophilized drug product dosage forms and other Steriles process development.

Platform development workstreams to assess, develop and implement new manufacturing platforms.

Drug Product technology transfer activities and reports as appropriate for transfer/scale-up to the manufacturing site (internal or external).

Prepare and review developmental and manufacturing batch records, SOPs, and regulatory documentation as appropriate.

Automate developmental work packages and establish control strategies through the development and maintenance of system modeling platforms.

Make innovative contributions to the department by leading platform development workstreams to assess, develop and implement new manufacturing/PAT platforms, for example lyophilization. Be an expert and be accountable for manufacturing/PAT platform robustness across the portfolio.

Author reports relevant to Process Engineering and analytics platforms.

Track assay performance metrics and communicate issues and suggest improvements to current assay methodology, supporting evaluation of new technologies where applicable.

Comply with Health and Safety procedures for own well-being and quality of product.

Actively seek opportunities to develop the service by discussion with the team leader and customer or by sharing the best practice with other groups.

Act as an ambassador for TLS and promote PerkinElmer’s core values.

Operate to approved quality standards.

Qualifications

• PhD in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.
• MS with 3+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.
• BS with 5+ years’ experience in Pharmaceutical Sciences, Biotechnology, Chemistry, Biology, Physics, Chemical Engineering, mechanical engineering or any engineering field. Experience in Freeze Drying/Lyophilization highly desired.

Preferred Qualifications

• Expertise in process development optimization, specifically lyophilized drug product manufacturing processes.
• Publishations in peer-reviewed journals.
• Experience in Steriles drug product process development, PAT, characterization, scale-up and technology transfer, and modelling.
• Experience in the application of state-of-the-art laboratory equipment, equipment automation, data automation, PAT tools and modelling software.
• Experience evaluating, developing, and qualifying manufacturing equipment.
• Proven ability to lead collaboratively in a matrix-style environment.
• Knowledge of GCP, GCLP, GMP, and data integrity principles in the pharmaceutical environment.
• Knowledge of 5S and/or 6 sigma principles is a plus.

Working Environment

• Employees will be provided with PerkinElmer polo shirts to be worn when on site.
• Must be able to work in a laboratory and controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.).
• Work with biohazards upon completion of blood borne pathogen surveillance.
• Hepatitis B vaccination may be required, vaccination programme in place for successful candidates who are not already vaccinated or require updated boosters. Opt out optional.
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time
• The person needs to occasionally move between laboratories, corridors, adjoining rooms, and buildings onsite. Occasional travel to other customer sites may be needed.
• Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus to perform the essential service functions of this position.
• Operation of a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• The employee may be required to manage hazardous waste in compliance with company procedures and local and national hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labelling.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.

Annual Compensation Range

The annual compensation range for this full-time position is $110,000 to $140,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.