Associate Director/Director, Analytical Development - South San Francisco, CA | Biospace
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Associate Director/Director, Analytical Development

Theravance Biopharma US, Inc.

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Location:
South San Francisco, CA
Posted Date:
9/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Development, Director,

Job Description


Job Purpose

Theravance Biopharma (South San Francisco, CA) is an established, progressive biopharmaceutical company focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal disorders. Our promising pipeline of internally discovered product candidates and strategic partnerships are elevating us to the next generation of drug discovery.
We have an opening for an Associate Director to Director level position in Analytical Development. This position will be part of a fast-paced analytical team responsible for supporting drug substance and drug product development.

Duties and Responsibilities

•   Lead and manage an Analytical Development group to support early stage clinical programs.
•   Exercise sound judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
•   Take a lead role for multiple development documents such as technical reports, validation reports, IND, EDP, CTD, patents, publications, posters, etc.
•   Lead the implementation and validation of analytical technology
•   Initiate and manage relationships to interact cross functionally
•   Accurate documentation of experimental details, as well as capability to critical review and approve the work of others for accuracy and compliance
•   Collaborate with related functions, including primarily chemical and pharmaceutical development colleagues
•   Direct, coordinate and monitor activities at contract labs
•   Ensures schedules, and performance requirements are met
•   Keeps abreast of state of the art analytical methodology and technology
•   Is recognized as an expert in a major area of Analytical Development.

Requirements


Qualifications

•   Ph.D. (or equivalent) with at least ten years of extensive pharmaceutical research, development experience
•   A minimum of three years of effective management experience in a cGMP environment
•   Technical proficiency in at least two areas of analytical development (i.e., compendial testing, separation sciences, spectroscopy and hyphenated technology)
•   Prior experience working in a regulated laboratory setting (GMP/GLP) in compliance with internal guidelines and SOP’s
•   Knowledge of scientific principles, laboratory skills and a commitment to laboratory safety, as well as the capability to effectively and critically apply these in daily activities Excellent oral and written communication skills
•   Capability to work independently and to multi-task effectively