Group Leader, Chemical Research & Development
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POST DATE 9/9/2016
END DATE 10/8/2016
JOB DESCRIPTIONGroup Leader, Chemical Research & Development
Help shape the future of a rapidly developing pharmaceutical services company. Alcami is a leading global provider of drug development and manufacturing to pharmaceutical and biotech companies around the world. We offer exciting and challenging career opportunities in a dynamic and growth oriented business.
Located in Germantown, Wisconsin, Alcami is part of the growing southeast Wisconsin biotech/pharma cluster. The area boasts global market leaders in contract pharmaceutical services, and a rapidly growing number of academic incubators. A short drive from Chicago, Madison and Milwaukee, Germantown offers residents a small town quality of life with convenient access to major Midwest cities. Residents enjoy an excellent school district and many local recreation attractions, in addition to national sports teams (Green Bay Packers and Milwaukee Brewers and Bucks), and a vibrant waterfront park community that includes world class art museums and children's museums.
Supervises and coordinates the activities of research and development laboratory operations. Ensures proper staff training; conduct key required training. Ensures that deliverables are met or expectations are proactively managed towards alternative solutions. Works on complex analysis of situations or data that requires an in-depth evaluation of various factors. Broadly defines practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Engages with business development and contract writing personnel to assist in project definition and costing.
KEY RESPONSIBLITIES AND DUTIES:
* Provide guidance to technical staff in the execution of their projects.
* Prepare project plans; track and report on progress, anticipate potential obstacles and proactively plan to avoid or address them.
* Train, mentor and supervise Senior Fellow or lower.
* Evaluate technical packages for prospective projects, consider technical options and resources required for each, and provide support for Business Development in the preparation of customer proposals and in closing new business.
* Prepare or edit project updates and reports, or other technical documentation.
* Participate in developing and/or revising strategic plans for the department.
* Participate in developing and/or revising training matrices for the department followed by execution of the training matrices.
* Contributes toward setting resource allocation and project timelines during project onboarding.
* Actively manages reports on adhering to timelines.
* Prepares documentation for setting specifications for raw materials, isolated intermediates and final products.
* Demonstrates the ability to work on and/or supervise the process development for a minimum of five projects at a time.
* Serves as a technical lead when the senior manager or associate director is unavailable.
* Performs audits of laboratory work and reports.
* Reviews and edits full development reports, participates in IND, NDA, aNDA and sNDA process and documentation.
* Performs other duties as assigned.
* PhD degree Organic Chemistry, with at least 8 years of relevant experience required including previous supervisory experience.
* Knowledge of API production to support drug development activities under cGMP following ICH and FDA regulations.
Alcami is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.