Senior Manager CMC - Permanent Position

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Location: Hatfield Knowledge Centre
Fulltime, 2 days a week onsite

The Company

Eisai is a leading research based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas.

By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

As a Senior Manager in CMC the main purpose of the position is:

• Provide CMC-regulatory services to support Eisai's success worldwide.
• Be accountable for execution of multiple projects and stakeholder's satisfaction.
• Collaborates with IPT and CMC teams supporting development projects towards license submission and approval.
• Provides CMC-regulatory support for established products including growth market submissions and any post-approval activities relevant to the drug substance and/or drug product.

Responsibilities will include but not be limited to:

Regulatory

• Ensures quality of deliverables and services to stakeholders for multiple projects/products.
• Take measures to keep Eisai's development projects and established products away from regulatory risk.
• Provide CMC-regulatory advice to project members.
• Have a good knowledge of quality guidelines and how to apply them.

CMC/Quality

• Establish CMC-regulatory strategy for projects/products.
• Lead preparation of CMC-regulatory documents.
• Attend CMC-regulatory meetings to solve issues on CMC/Quality for development or marketed projects.
• Lead preparation of Module 3 sections.
• Review changes proposed by QA/manufacturing and take any necessary CMC-regulatory actions to implement the changes.
• Liaise with affiliates/distributors in new markets on CMC-regulatory issues.

Development

• Evaluate CMC-regulatory processes and propose solutions to improve Eisai's CMC-regulatory activities.
• Propose how Eisai can be a patient oriented hhc company.

What are we looking for?

• College or University degree in an associated functional discipline (Chemistry, Biological Science or Pharmacy)
• Doctorate or higher degree desired (e.g. MSc, JD, Pharm D, or PhD in life sciences)
• Previous CMC-regulatory-related experience plus additional related experience (i.e., in Research and Development or Manufacturing, Quality Assurance, Quality Control etc.), preferably including some broader industry/academia experience
• Possess working knowledge on the formulation and/or analytical aspects of R&D in addition to the above CMC-regulatory related experience
• A working knowledge on the principles of chemistry/biochemistry to drug substance manufacture
• Experience in the development of solid and/or parenteral dosage forms, including process validation.
• Experience dealing with agencies, preparation of briefing documents and holding agency meetings relating to CMC/Quality issues.

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes,

• Hybrid working, 2 days onsite
• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application.

We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society.
Our commitment is:

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity