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Validation ( Process ) / Technical Manager


Milford, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job Description

Validation (Process)/Technical Manager
Milford, MA

At NITTO DENKO Avecia, teamwork is the key to our success. Every day, the people here are helping to bring great medical discoveries to life.  The work we do and innovation we deliver mean that you, as an employee, are directly involved in helping lay the groundwork for the next great biotech innovation.

Our commitment to work/life balance gives each and every employee the space to enjoy life, their families and friendships outside of work. Flexible time off and flexible schedules, are some of the ways we encourage a good work/life balance.

Here, You Make a Difference.

Reporting to the Senior Director, Process Development this role will provide strategic leadership and support of process validation activities for Avecia's manufacturing processes.

Key job responsibilities:
* Ensure Avecia's process validation programs are structured and executed such that they meet appropriate industry expectations and requirements (with consideration for both CDER and CBER requirements) working closely with the Company's internal regulatory representatives.
* Provide strategic leadership and direction in support of validation activities specific to manufacturing processes, internally and with clients
* Ensure consistency and standardization of approaches to process validation across projects and sites
* Mentor and train cross functional teams in requirements for and execution of process validation programs
* Write/oversee writing of relevant internal procedures and guidance related to process validation
* Write/oversee writing of product specific validation master plans
* Provide oversight of activities executed to support process design/characterization, process performance qualification and continued process verification


Qualifications/skills/experience required:
* PhD in Chemistry and 7 years experience or BSc in Chemistry and 10 years of relevant experience
* In depth knowledge of cGMP including ICH guidances, and US and European process validation requirements
* Minimum of five (5) years of applied validation experience.
* Experience of working in a cGMP environment with specific experience in leadership of process validation programs and working with commercial products
* Experience of process development, scale up and manufacturing of APIs/intermediates
* Proficiency in preparation of technical presentations, reports and publications in the English language

EOE AA M/F/Vet/Disability

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