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Director/Senior Director Process Sciences

Employer
Hobson Prior
Location
Gaithersburg, USA, Maryland
Salary
£139429.98 - £180438.79 per annum
Start date
13 Jan 2021
Closing date
8 Feb 2021

View more

Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Hobson Prior are recruiting for a Director/Snr Director Process Sciences to join a biotech organisation, focusing on improving health all over the world through discovering and developing vaccines to prevent serious diseases. This is a permanent position, located in Gaithersburg Maryland.

Job Responsibilities:

  • Providing technical leadership to generate, review, and approve laboratory data to support investigations and troubleshooting of drug substance processes being operated at internal and external manufacturing.
  • Contribute to the writing and reviewing of documents for INDs and regulatory section submissions.
  • Collaborate with other CMC team members to build and execute the CMC development plan.
  • Responsibility for continued process verification, including process monitoring programs across multiple manufacturing programs and manufacturing sites.
  • Responsible for technical oversight of supplier-initiated changes and DS process changes.
  • Lead and develop a team of laboratory personnel.
  • Provide leadership and direct support for tech transfer to manufacturing teams, including the preparation of draft batch records.
  • To plan and execute confirmation runs (or manage and oversee execution of confirmation runs at external sites).
  • Prepare or oversee the preparation of tech transfer reports and participate in the approval to move towards GMP manufacturing.
  • In conjunction with site management, make key process related decisions when necessary.
  • Establish appropriate process performance monitoring systems and assist in evaluating process performance.
  • Any other assigned duties.

Key Skills:

  • Ability to succeed in a team-oriented environment under very dynamic conditions.
  • Ability to collaborate with key stakeholders across a wide set of business disciplines.
  • Excellent record keeping abilities to adequately record, analyse and document data generated in support of regulatory requirements.
  • Demonstrated verbal and written skills in communicating scientific and technical information.
  • Capable of performing multiple functions in a fast-paced environment.
  • Strong technical protocol/report writing, and good organization skills are required.

Requirements:

  • Master's degree in engineering or life sciences.
  • You will have 10 or more years of relevant experience in cGMP biologics manufacturing.
  • Diverse knowledge and experience in various relevant areas, including but not limited to molecular/cell biology, harvest, formulation and common analytical tools is preferred.
  • Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products.
  • Proficient in Window based software including Excel, PowerPoint and Word.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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