The purpose of this position is to provide senior leadership and management of the analytical methods development and stability for the pipeline product candidates as they progress through early development to commercialization, including technical transfer to Quality Control. In addition, this position will also be responsible for the appropriate segment of technical transfer in expansion of commercial product manufacture.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
1.Provide leadership and guidance in the design and execution of analytical methods development and qualification appropriate for the developmental stage
2.Design department quality systems and procedures for development of analytical methods and use and maintenance of analytical instrumentation.
3.Oversee in-process testing of process intermediates during process development and scale-up.
4.Responsible for product initial release testing for non-clinical and clinical studies.
5.Design stability program for pipeline product candidates.
6.Provide an oversight for analytical testing of in-process samples in a support of technical transfer of products to another manufacturing sites in the US and UK.
7.Critically evaluate the experimental results of all group members.
8.Summarize findings for presentations, technical reports, and manuscripts.
9.Prepare documents for regulatory submissions and/or review (e.g. investigation new drugs (INDs), new drug applications (NDAs), standard operating procedures (SOPs), standard test methods (STMs), qualification and validation protocols and reports).
10.Represent department at project team meetings.
11.Provide team leadership. Coordinate project goals and tasks. Act as liaison with corporate partners.
12.Maintain high level of technical knowledge in areas of responsibility.
13.Apply the knowledge, skills and experience obtained to increase efficiency in solving new problems.
14.Provide training and technical assistance to less experienced lab personnel.
15.Comply with cGMPs where appropriate.
16.Maintain cooperative working relationships with other departments (e.g. QC, QA, process development, regulatory).
17.Maintain good documentation and exercise clear, concise communication skills.
Education and Experience:
•M.S or PhD in analytical chemistry or relevant field of study from an accredited college or university + at least 10 yr progressively responsible analytical methods development experience and 6 yr management experience. Prior experience in analytical development for new drugs.
Extensive knowledge of current Good Manufacturing Practices (cGMPs). Thorough knowledge of current regulatory requirements, guidelines and standard industry practices for analytical methods development, qualification and validation throughout product life cycle.
2.Proficient in the use of and well versed in the maintenance of laboratory equipment such as HPLC and GC.
3.Strong organizational skills (e.g. daily tasks, documentation, archived information).
4.Strong interpersonal skills (e.g. working with members of other teams to achieve shared goals).
5.Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
6.Hands-on approach with a strategic and operational focus; capable decision maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes. Collaborative leader able to operate effectively and with a strong sense of urgency in a fast-paced environment.
7.Organized problem solving and troubleshooting skills (e.g. rational progression of investigation).
8.Thorough understanding of the chemical and physical principals upon which formulation, process development and analytical methodology is based.
9.Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.
10.Excellent documentation skills (e.g. notebook, reports).
11.Outstanding communicator: direct, effective, clear, concise, well organized and appropriate. (e.g. able to participate in scientific discussions and written interactions).