Associate Director, Technical Operations

At Proclinical, we are seeking an individual to fill the newly-opened role of Associate Director of Technical Operations, based in San Diego, CA. The successful candidate will develop and maintain operational systems that enable GXP activities in the development and commercial environment and will create and manage appropriate CMC documentation to be used internally and with vendors.

Responsibilities

• Establish processes to manage third party vendors.
• Assist in document development with third party vendors.
• Initiate, monitor and track change control processes for drug product and supply chain activities.
• Help with design packaging and labelling configurations and documentation.
• Collaborate with Quality Assurance on vendor qualification and maintenance processes.
• Assist with laboratory and manufacturing deviations, investigations and CAPA implementation activities for all GMP vendors.
• Establish and prepare analytical, manufacturing and supply chain metrics for annual reviews and management updates.
• Assist Quality Assurance with vendor audits when necessary.
• Author, review and/or approve documents related to GMP operations.
• Assist in establishing timelines, goals and budgets.

Skills And Qualifications

• BA or advanced degree in Chemistry or related science required.
• 10+ years' experience in a GMP pharmaceutical or biotech industry or related required.
• Understanding of pharmaceutical development requirements for small molecule based drugs.
• Working knowledge of CGMPs and applicable international regulations and guidelines.
• Understanding of global CMC requirements and documentation for IND and CTD submissions.
• Experience with wet chemistry, manufacturing and supply chain.
• Familiar with late phase method and process validation for small molecule pharmaceuticals during clinical and commercial development.
• Experience in working with third party vendors including project management and auditing.
• Proficiency in Microsoft Office.
• Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 6468786308 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.