The Downstream (purification) Process Science team is a group of Scientists and Subject Matter Experts who specialize in the development optimization remediation and transfer of the downstream processes used in cGMP commercial manufacturing of drug substance. This position is primarily a lab-based role which requires hands-on execution of downstream development optimization and characterization experiments using small-scale chromatography models along with analysis and interpretation of experimental data.
PRIMARY RESPONSIBILITIES
- Supports and contributes to laboratory experiments related to the development optimization characterization and scale-up of downstream protein purification processes.
- Executes assigned experiments that support process development activities and project goals using semi-preparative chromatography membrane technology and low-pressure chromatography (ion exchange affinity size exclusion).
- Quantify and characterize protein targets and impurities using typical protein analytical methods (HPLC DSD-PAGE western blotting UV-VIS spectrophotometry etc.)
- Analyze data interpret results form conclusions and assist in planning future studies in a collaborative environment.
- Provides downstream technical support for cGMP manufacturing operations by contributing insights to solve routine technical issues. Provides support for technology transfer of downstream processes to a cGMP facility.
- Actively participate in idea generation including identification and optimization of alternative laboratory methods and/or equipment in support of continuous process improvement and process life cycle management objectives.
- Communicates work through oral presentations and written documentation including technical reports.
- Author/review development protocols development reports SOPs and batch records
- Uses professional concepts to complete data entry data analysis and maintenance of accurate experimental records.
- Collaborates with key partners (upstream scientists analytical scientists and manufacturing and quality colleagues).
KNOWLEDGE SKILLS ABILITIES
Required:
- Working experience with typical downstream purification processes including semi-preparative chromatography membrane technology (TFF) and low-pressure chromatography (ion exchange affinity size exclusion).
- Working experience with fundamental protein analytical methods
- Demonstrated strong organizational interpersonal and project management skills.
- Ability to work independently and provide training to junior team members.
- Ability to independently make decisions based on data scientific knowledge and sound judgement.
- Excellent communication skills both written and oral.
- Maintain a safe work environment in accordance with policies procedures and regulations.
Preferred:
- Experience with peptide mapping and LC/MS desirable
- Understanding of ICH and FDA guidelines
- Working knowledge of statistical analysis techniques (standard deviation t-test p-value) Design of Experiments (DOE) and associated software (JMP etc.).
EXPERIENCE & EDUCATION
Required:
- B.S. in a scientific or engineering discipline and a minimum of 2 years related experience; or a M.S. and 0-2 years. Knowledge of scientific principles and concepts.
Preferred:
- B.S. or M.S. in Bioengineering Chemical Engineering and Chemistry.
PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $74000 - $92500: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.
In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes an annual cash bonus 401k matching free parking or Seattle-area ORCA pass tuition assistance plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.
Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.
Required Experience:
IC
The Downstream (purification) Process Science team is a group of Scientists and Subject Matter Experts who specialize in the development optimization remediation and transfer of the downstream processes used in cGMP commercial manufacturing of drug substance. This position is primarily a lab-based r...
The Downstream (purification) Process Science team is a group of Scientists and Subject Matter Experts who specialize in the development optimization remediation and transfer of the downstream processes used in cGMP commercial manufacturing of drug substance. This position is primarily a lab-based role which requires hands-on execution of downstream development optimization and characterization experiments using small-scale chromatography models along with analysis and interpretation of experimental data.
PRIMARY RESPONSIBILITIES
- Supports and contributes to laboratory experiments related to the development optimization characterization and scale-up of downstream protein purification processes.
- Executes assigned experiments that support process development activities and project goals using semi-preparative chromatography membrane technology and low-pressure chromatography (ion exchange affinity size exclusion).
- Quantify and characterize protein targets and impurities using typical protein analytical methods (HPLC DSD-PAGE western blotting UV-VIS spectrophotometry etc.)
- Analyze data interpret results form conclusions and assist in planning future studies in a collaborative environment.
- Provides downstream technical support for cGMP manufacturing operations by contributing insights to solve routine technical issues. Provides support for technology transfer of downstream processes to a cGMP facility.
- Actively participate in idea generation including identification and optimization of alternative laboratory methods and/or equipment in support of continuous process improvement and process life cycle management objectives.
- Communicates work through oral presentations and written documentation including technical reports.
- Author/review development protocols development reports SOPs and batch records
- Uses professional concepts to complete data entry data analysis and maintenance of accurate experimental records.
- Collaborates with key partners (upstream scientists analytical scientists and manufacturing and quality colleagues).
KNOWLEDGE SKILLS ABILITIES
Required:
- Working experience with typical downstream purification processes including semi-preparative chromatography membrane technology (TFF) and low-pressure chromatography (ion exchange affinity size exclusion).
- Working experience with fundamental protein analytical methods
- Demonstrated strong organizational interpersonal and project management skills.
- Ability to work independently and provide training to junior team members.
- Ability to independently make decisions based on data scientific knowledge and sound judgement.
- Excellent communication skills both written and oral.
- Maintain a safe work environment in accordance with policies procedures and regulations.
Preferred:
- Experience with peptide mapping and LC/MS desirable
- Understanding of ICH and FDA guidelines
- Working knowledge of statistical analysis techniques (standard deviation t-test p-value) Design of Experiments (DOE) and associated software (JMP etc.).
EXPERIENCE & EDUCATION
Required:
- B.S. in a scientific or engineering discipline and a minimum of 2 years related experience; or a M.S. and 0-2 years. Knowledge of scientific principles and concepts.
Preferred:
- B.S. or M.S. in Bioengineering Chemical Engineering and Chemistry.
PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $74000 - $92500: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.
In addition to medical dental vision FSA/DCA HRA disability and life insurance coverage all full-time regular Partners enjoy a casual and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes an annual cash bonus 401k matching free parking or Seattle-area ORCA pass tuition assistance plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy wellness participation programs and a generous vacation sick and holiday paid time off program in addition to a paid shutdown between the Christmas and New Years holidays.
Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race color religion sex age national origin veteran status marital status sexual orientation gender identity disability or any other category prohibited by local state or federal law. This policy applies to all aspects of employment including recruitment placement promotion transfer demotion compensation benefits social and recreational activities and termination.
Required Experience:
IC
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