Director, Analytical Development

(Job Id W314236)
Posted on 4/28/2010
Location:

Cambridge, MA


Job Type:

Full Time


Salary: $160000.00 to $210000.00/year
Degree: Doctor of Philosophy
Job Description
Develop analytical strategy and integrated analytical plans for protein products during clinical development and support of products life cycle, assuring that regulatory requirements are met. Oversight of product characterization and release/stability testing during clinical development phase. Develop analytical departments budget, and deliver analytical departments goals within budget and timelines. Develop specifications strategy and justification to internal and external authorities. Develop departments technical and product development capability and manage a large department ranging in experienced scientists and analytical specialists. Responsible for assuring GMP compliance as applicable.
Essential Functions
Responsibilities
Describe the essential job duties. After each, provide an estimate of the percent of time typically devoted to each responsibility (use increments of 5%, all time spent should total to 100% of time allocation). To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Please note the percentage of time spent on each job duty is an estimate for normal operating conditions.

Assure development of scientifically sound and robust analytical methods for release and stability testing, and characterization of product and impurities, appropriate for each product development phase.
Oversight of tech transfer of analytical methods to the Quality dept.
Oversight of authoring CMC sections for regulatory submissions and responding to questions.
Oversight of release and stability testing of products during clinical phase until transfer of methods to QC.
Effective interface with Pharmaceutical groups, other Process Development groups, Quality, Regulatory, and Manufacturing; develop systems that meet customer needs, including high throughput testing for Process Development support.
Develop continuous improvement plans, including processes and guidelines for efficient product development, project review and prioritization
Assure GMP compliance in department
Meet timelines and deliverables within budget; prioritize projects as appropriate
Develop personnel technical and product development capability

Technical management: 55%
Interface customers, management, teams: 30%
Compliance: 15%


Education & Experience Requirements
Include educational requirements or equivalency, required years and type(s) of experience, and necessary licenses or certificates. Specify which are required and which are preferred.



PhD with at least 10 years experience in developing analytics for glycoproteins, writing regulatory submissions of CMC sections, and managing scientists and technical personnel.
Working knowledge of GMP compliance as related to analytical laboratory
Technical expertise in protein chemistry and product characterization
Expertise in CMC areas of product development, including regulatory requirements for developing and setting product specifications
Strong and effective people management and interpersonal skills, and demonstrated leadership to provide direction to a large department in a fast paced, multi-product biotech company
Clear and concise communication skills, both written and spoken; specifically has demonstrated strong experience and skills in authoring regulatory submissions
Demonstrated technical project management experience to develop integrated short term and long term project plans



Key Skills and Competencies
Describe critical skills needed to successfully perform job, which should be representative of the knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Technical excellence in analytical and glycoprotein chemistry
Business knowledge of CMC product development
Strategic agility and effective influence management skills
Clear and concise written and oral communication skills, with capability to position regulatory technical contents in the CMC area
Team player with excellent interpersonal skills
Effective people development and people management


Other Job Components
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the incumbents authority to make as well as those decisions that must be referred to a higher level.

Ability to rigorously design complex analytical and product development strategies for parallel development of multiple projects.
Critical evaluation of results and strategic guidance to reach resolution to technical and product development issues
Drive and energy to multi-task in a face pace environment, with flexibility and strength to navigate through technical crises

Internal and External Contacts
List contacts this job advises, consults and coordinates with on a regular basis. Describe to whom this job is accountable. Indicate each Contact Category (Internal, Vendor, Customer, or Other) and provide examples.

Provides strategic guidance to internal scientists; negotiates project plans across PD and external customers, presents analytical strategy to management, rationalizes specifications to senior management.

Other Requirements
List any other job requirements, including domestic travel, international travel, drivers license, physical abilities required, etc.
Low level travel, potentially to contract laboratories and scientific meetings