Scientist I or II - Purification - Rockville, MD, MD | Biospace
Get Our FREE Industry eNewsletter

Scientist I or II - Purification

MacroGenics, Inc.

Apply
Location:
Rockville, MD, MD
Posted Date:
2/16/2017
Position Type:
Full time
Job Code:
16-728
Salary:
$70,000-$105,000
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Summary of Position

This position is responsible for the development, characterization and validation of purification processes for late-stage pipeline products. The individual will help establish late stage characterization and validation strategies while also participating in process development activities.  The position necessitates a collaborative approach with other Development functional groups, Manufacturing, Validation and Regulatory Affairs towards the goal of transitioning products from development to commercialization.

Responsibilities and Job Duties:
* Establish process characterization and validation strategy
* Design, coordinate and execute process characterization studies
* Design and execute small scale and large scale validation studies
* Presentation of validation and characterization study results to internal teams
* Draft protocols and reports in support of regulatory filings
* Write the relevant sections for regulatory submission

Requirements

Scientist I:
Education
BS, MS, or PhD in the biological sciences or related field

Experience
BS with a minimum of 12 years of experience, MS with a minimum of 9 years of experience or PhD with no previous experience
Minimum of 5 years of biotech industry experience

Scientist II:
Education
BS, MS, or PhD in the biological sciences or related field

Experience
BS with a minimum of 14 years of experience, MS with a minimum of 11 years of experience or PhD with a minimum of 2 years of experience
Minimum of 5 years of biotech industry experience

Knowledge, Skills and Abilities – Scientist I and II
Possess in-depth understanding of downstream unit operations
Understanding of downstream process development and process transfer to manufacturing
Demonstrated ability to perform small-scale model studies using Design of Experiments (DOE) approach
Experience operating purification equipment such as AKTA or equivalent
Proven track record of authoring, executing and reviewing both large and small scale validation protocols
Ability to collaborate with and influence other functional areas such as Regulatory Affairs and Process Validation
Excellent technical writing skills and oral communication skills
High energy results driven individual
Willingness to be hands on
Preferred Qualifications – Scientist I and II
Experience performing biologics analytical techniques (HPLC, Capillary Electrophoresis, ELISA)
Previous management experience

Supervisory Responsibilities:
None