Amgen

PD Senior Scientist Biological Relevance and Characterization

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 18, 2019
Ref
R-75809
Required Education
Bachelors Degree
Position Type
Full time
This position is responsible for developing, qualifying and transferring state-of-the-art and fit-for-purpose quantitative potency and characterization assays and supporting regulatory submissions.

Basic Qualifications

Doctorate degree & 2 years of relevant scientific experience

OR

Master's degree & 4 years of scientific experience

OR

Bachelor's degree & 6 years of scientific experience

Preferred Qualifications:

Expertise in cell culture and cell biology techniques for quantitative determination of biological activity of proteins

Expertise in cell-based bioassay development (method characterization, qualification, validation, technical transfer)

Expertise in virology and oncolytic viruses preferable

Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies

Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines

Experience with flow cytometry

Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines

Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization

Resource management - Ensures resources are utilized fully and productively and that adequate resources are projected and selected to accomplish unit responsibilities

Innovation - positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others' creativity to improve unit performance

Client orientation- establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered

Performance management - ensures direct reports are adequately oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning

Leadership - establishes and implements strategy using an appropriate leadership style; builds teamwork and collaboration

Communication - Excellent written and oral communication skills. Establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary

Interpersonal skills - communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood.

Responsibilities include:

Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations

Authoring technical reports for investigations, product and impurity characterization, and regulatory submissions

Generates, analyzes, and interprets analytical data to support product development, investigations, and regulatory submissions

Guides resolution of scientific/technical issues

May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by communicating analytical updates, analytical documentation and data

Determines detailed analytical procedures for release, stability, and product characterization testing, including timelines, milestones, methodological approaches, expected results, and necessary resources

Works independently and integrates output into overall project deliverables

May manage a team of lab associates to accomplish project deliverables

Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities and applies this knowledge to the evaluation and development of new methodologies

Recognized as a scientific resource in area of expertise