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Associate Director, Technical Services

Location

Whippany, NJ, USA

Department

Technical Services

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

The Associate Director, Technical Services is responsible for process, cleaning and packaging validation activities. Responsible for managing, developing and implementing validation programs and processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices.  

Supports commercial manufacturing and packaging operations for process improvements and optimization. Partners with product development on technology transfer, process development and product commercialization. Directs the activities for manufacturing and packaging master batch record preparation. Creates and manages a department vision that aligns with the organization’s strategic plan.

Responsibilities also include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages.
Responsibilities also include directing or participating in: performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability.
Applies statistical analysis and design of experimental approaches to process development activities.
Develops and administers budgets, schedules and performance requirements. Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Technical Services/Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
Participate in developing Divisional procedures and guidelines
Participates in audits conducted by the client, regulatory agencies and internal Cambrex personnel.
Manage, identify, hire, develop and recognize technical staff; Create and maintain employee and organizational development; as well as HR plans which meet business needs.
Apply specialized knowledge in a creative way to a broad range of difficult problems.
Approve protocols and support documentation (change requests, system change forms, etc.) in order to secure project release.
Manage generation and approval of cGMP master batch records for manufacturing and packaging operations.

Qualifications:
Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Also must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. Able to manage multiple cross-functional teams simultaneously.
Proficient in Microsoft Word and Excel, computer software.
Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.
Knowledge of GMPs, FDA guidelines, process/cleaning validation and product technology transfer.
Ability to manage multiple cross-functional teams simultaneously.
Ability to design and influence outside of immediate scope of responsibility.
Proven track record of management/leadership effectiveness.
May be required to move about the facility
May be required to wear personal protective equipment
May be required to remain sedentary for periods of time

 

EDUCATION:  

Minimum of a BA or BS preferably in the Life Sciences/Engineering/Math/Chemistry or other job-related discipline.

 

EXPERIENCE:

A minimum of 10 years related experience in Technical Services/Validation within a pharmaceutical, biotech, devices, or related industry. 3 years of project management experience required