Career

Manager, Process Support and Manufacturing

Location:  Stockholm, Sweden

Primary Job Responsibilities:
This position supports CMC manufacturing with an emphasis on CMO oversight, process validation and process transfer.

Provides technical support to manufacturing including GMP document review, process data review and trending, review and input into technical investigations and process validation.    Works with the CMOs to provide day-to-day oversight and to act as a person-in-plant as needed during manufacturing campaigns.

This position will also support process transfer of current manufacturing processes to alternate CMOs.

Position will provide significant input to regulatory filings such as INDs, IMPDs, and market applications.

Job Requirements:
MS in biochemistry or biochemical engineering with a minimum of 7- 9 years experience in process development and manufacturing within the biotech industry.    Must be proficient in microbial fermentation and lyophilization process development and manufacturing with a working knowledge of current ICH, FDA, and EMEA guidelines.    Must have experience working with CMOs.      Experience with cell banking and anaerobic fermentation is highly desirable.

The candidate must possess strong leadership, communication and interpersonal skills.

The candidate must be proficient in Swedish and English.

Approximately 25% travel is required for this position.

 

Manager, Drug product process support and analytics

Location:  Stockholm, Sweden

Primary Job Responsibilities:
This position supports CMC drug product development and manufacturing.   In addition, this position supports analytical development and validation for a late-stage product.

Provides drug product expertise including formulation development, drug product process support and oversight of drug product manufacturing.    Provides technical support to manufacturing including GMP document review, process data and trending and input into technical investigations as needed.

Provides analytical support associated with characterization, method development and validation, stability, and batch release.  This position requires implanting and monitoring outsourcing activities with external contract laboratories.

Position will provide significant input to regulatory filings such as INDs, IMPDs, and market applications.

Job Requirements:
MS in biochemistry or biochemical engineering with a minimum of 7- 9 years experience in formulation development and manufacturing within the biotech industry.    Must be proficient in formulation development for lyophilized products using capsule technology.   Must be proficient in analytical method development and validation with a working knowledge of current ICH, FDA, and EMEA guidelines.    Must have experience working with CMOs.      Experience with live cell therapeutic products is highly desirable.

The candidate must possess strong leadership, communication and interpersonal skills.

The candidate must be proficient in Swedish and English.

Approximately 25% travel is required for this position.