12 days old

Principal Engineer Combination Product Development


Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY

Reporting to the Director, Combination Product Development & Integration, the position of Principal Engineer, Combination Product Development, will provide technical leadership in the design, development, manufacture, and testing of drug-device combination products such as injectables and nasal sprays.

The Principal Engineer, Combination Product Development will be responsible for the development, compilation and maintenance of the design history file, risk management file and human factors engineering file of drug-device combination products from identification of user needs, conceptualization, design and development, transfer to manufacturing, product launch and life-cycle management.

In collaboration with Drug Development and Device Development technical leads and other relevant stakeholders, the Principal Engineer, Combination Product Development will be responsible for the technical interface between the constituent parts of the combination product during development ensuring products are developed and manufactured according to regulatory and GMP, ICH, ISO and other applicable requirements.

II. ESSENTIAL FUNCTIONS


Technical lead on a project to integrate drug product and device constituent part development into combination product development and commercialization of new products and life-cycle management activities of commercial products.
Technical interface between drug product and device development teams to support CMC development plans related to drug-device combination product development with emphasis on container closure development, biocompatibility, microbiological attributes, stability, and sterilization process development
Oversight and management of design history file compilation and maintenance
Oversight and management of combination product risk management
Oversight and management of human factors engineering activities
In collaboration with drug product and device development SMEs, establish the combination product manufacturing strategy, equipment, and process flow
Lead activities in manufacturing process development of the combination product
Lead combination product manufacturing campaigns and responsible for providing technical inputs, batch record reviewpproval, and on-site presence for development, clinical/registration campaigns
Established critical process parameters and establish control strategy to support combination product manufacture for product registration and commercial manufacture
Develop and generate in-process, intermediate, release, stability specifications for combination products
Technical oversight of team responsible for design transfer of combination product
Provide peer review and technical inputs on the key regulatory submission documents, e.g., NDA, FDA Type C, EMA scientific advisory
Responsible for leading a technical team during regulatory and notified body inspections by representing the team in front of auditors and ensuring audit readiness
Responsible
Write study protocols, technical reports and SOPs
Analyze and present data to cross-functional project teams, leadership and CMO
Conduct all work in compliance with Emergent Standard Operating Procedures and regulatory requirements.
Contribute to the establishment of combination product development procedures and practices within the R&D unit

.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
A minimum of a Bachelor's or advanced degree in the field of Pharmacy, Pharmaceutical Sciences, Mechanical Engineering (or similar disciplines). Masters degree or PhD preferred.
5+ years of experience in drug-device combination product research and development is essential. 10+ years is preferred.
5+ years direct experience in pharmaceutical development and/or medical device development including manufacturing process development and scale up from lab scale to pilot scale to commercial production.
Direct experience of quality by design principles and application of ICH principles to pharmaceutical development.
Direct experience of generating and managing design control documentation as per the requirements of FDA 21 CFR part 820 and ISO 13485 Design Control is essential.
Direct experience with generating documentation for CMC for regulatory filings for pharmaceutical products is desired.
Direct experience in the application ISO 14971 Risk Management for Medical Devices to product development is essential.
Experience in design, development and qualification of a broad range of pharmaceutical drug-device combination products such as: pre-filled syringes, autoinjectors, long acting injectables, nasal sprays and implantable dosage forms.
Experience in the development of sterile products.
Experience of injection molding process development and tool design is desired.
Experience in developing automated manufacturing equipment is desired.
General experience of clinical trials.
Proficiency with 3D computer-aided design (SolidWorks) is desired
Experience with Design of Experiments (DOE) and statistical analysis is desired
Knowledge of human factors engineering principles for medical device and combination product development. Direct experience in human factors engineering is desired.
Thorough knowledge of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products
Demonstrated ability to create and execute to technical plans and timelines (MS Project preferred)
Track record of successfully managing third-party sub-contractors is essential.
Strong communication skills and ability to drive cross-functional decision making
A true self starter, who works effectively on their own initiative, and is used to working in demanding environments, where there is continuous change and ambiguity.
Highly organized, with exceptional time management and prioritization
Critical thinking evaluation of process problems
Strong work ethic
Flexibility to travel on company business when required.

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Categories

Industry

  • Biotechnology
Posted: 2022-05-09 Expires: 2022-06-08

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Principal Engineer Combination Product Development

Emergent BioSolutions Inc.

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