Principal Engineer, Oral Solid Dosage Packaging

About Servier

With commercial stage products and a promising pipeline, we are a US-based affiliate of Servier Group, a unique global organization headquartered in France. Operating in more than 150 countries and governed by a non-profit foundation, we have multiple medicines approved in oncology, & other disease states globally. Additionally, we have accelerated our investments with an ambition to further establish ourselves as innovators in the Oncology space. Over half of our research and development efforts are specifically focused on delivering significant advances in targeted therapies to treat patient communities with unmet needs.  At Servier, you will join a highly skilled team dedicated to bringing the promise of tomorrow to the patients we serve.

Role Summary

This position will provide technical oversight of Oral Solid Dosage bulk drug product and finished goods labelling, packaging, and serialization operations at external sites for multiple commercial programs. In addition, this position will be responsible for labelling and packaging components and processes for outsourced activities including technology transfers and support of regulatory submissions, launches, and post-approval changes.

Primary Responsibilities

• Day-to-day technical oversight of activities at external CMO partners
  • Establish/Lead technical oversight of labelling, packaging and serialization activities at Contract Manufacturing Organizations (CMO) in accordance with Servier CMC and External Manufacturing organization framework
  • Proactively drive technical deviation investigations, change implementations and continuous improvement activities in alignment with Technical Team and Virtual Plant Team goals
  • Collaborate efficiently with Regulatory, Quality, Operations, Supply Chain and extended teams
  • Establish/Maintain labelling and packaging process monitoring for commercial products as part of robust Continuous Process Verification
  • Evaluate engineering drawings and specifications to determine physical characteristics of item, special handling, environmental and safety requirements, and types of materials required for packaging
  • Oversee creation and maintenance of packaging artwork
  • Oversee and maintain packaging specifications
  • Troubleshoot packaging concerns involving designs, materials and processes and provide creative, timely, and cost-effective solutions
• Author/Review CMC related sections for regulatory filings (New markets and Post Approval Changes)
• Technology Transfer and Validation
  • Lead technology transfers, validation activities as required
  • Support packaging equipment qualification protocols and process validation strategies (Engineering Studies/OQ/PQ/PV) in conjunction with CMOs
  • Support shipping qualifications
• Cross-functional team leadership and participation
  • Lead Packaging project team as needed including issuance of meeting agenda, hosting meeting and issuing minutes
  • Actively participate in Virtual Plant Team
  • Represent MSAT on packaging topics in different teams as needed with Regulatory, Marketing, Product Strategy Leads
  • Be the Servier point of contact for all packaging topics and coordinate discussions/meetings with Packaging team at CMO
  • Facilitate determination of technical project timelines and track timelines
  • Facilitate determination of technical project impact on supply and budget
• Subject Matter Expertise (SME)
  • Perform process risk assessments to define improvements and mitigate gaps as per Quality and Regulatory requirements and industry best practices
  • Remain up to date with latest trends, technologies and best practices in oral solids packaging development and processes through professional organizations, peer reviewed literature, trade journals and vendor sources.
• Other duties as required by management

Education and Required Skills

• Minimum B.S. Degree in Packaging Engineering or equivalent with a minimum of 8-10 years of relevant experience or M.S. or PhD in Pharmaceutical Sciences or Chemical Engineering with a minimum of 5-8 years of relevant experience in pharmaceutical packaging development and production including experience with regulatory support and launch
• Detailed understanding of primary, secondary, and tertiary packaging solutions for oral solid dosage products
• Understanding of current principles and applications behind the packaging materials testing and performance requirements as defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidance documents along with a general understanding of technical packaging requirements in EP and JP
• Experience in serialization process including knowledge of relevant regulatory guidelines
• Extensive knowledge of innovative packaging solutions and expertise on emerging trends for innovative packaging technologies
• Working knowledge of oral solid dosage forms
• Global product launch experience
• Expertise in use/application of basic statistical methodologies and softwares (e.g., Minitab, JMP or equivalent)
• Experience in collaborating with Contract Development / Manufacturing Organizations and external partners
• Expertise in use/application of variety of problem-solving tools e.g. Ishikawa, Kepner-Tregoe (KT), five-whys, etc.
• Strong ability to strategically plan, organize, and manage multiple projects simultaneously
• Demonstrated track record of creativity and problem solving in projects
• Strong interpersonal skills and demonstrated accomplishments working in interdisciplinary teams
• Strong knowledge of relevant GxPs as well as applicable multinational regulatory guidelines
• Proficient with basic Project Management skills
• Ability to effectively operate in an environment that requires collaboration, influencing skills, negotiation skills, and analytical judgment
• Excellent written/oral communication and presentation skills
• Strong analytical skills and attention to detail

Travel and Location

• Domestic and international travel up to 20%
• Preferred location is in Boston, USA, but position is amenable to remote work

Servier’s Commitment

We’re an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.