Scientist

Description

100% Onsite, or Hybrid Onsite Schedule: Hybrid (4 days onsite), Monday or Friday can be possible to work from home

Manager's update

• This position is in the Product Development of new injectables
• The group is antibody drug conjugates, and other folks are working in biologics
• Looking for experience with injectable development and particularly with biologics
• Wrong on antibody drug conjugates
• Comfortable working in the lab environment
• Helping the scientist with the design of the experiments
• Working with lyophilization products and liquid injectables
• Helping with some of the compounding process, filling, and lyophilization
• Management of the sample’s different storage conditions
• Working with commercial in use studies and stability studies
• Reconstitute the dilute product
• Perform stability studies on the samples
• Experience with formulation robustness
• Doing lot of lyophilization mapping, filtration studies
• If the candidate is not having ADC experience but has parental development experience will work
• Parental formulation dossege ex[prince high preference
• Having the experience with biologics is it’s a plus
• An injectable background is must have
• This group is focused on ADC projects
• understand the protocol
• Take ownership over the experiments
• Contributing to the design of the studies with the supervision of a senior scientist
• Responsible for ensuring that we have the materials
• Collect the data interpret the data and help with the report drafting
• 7 years with bachelor's and master's degrees with 3 years of experience
• Experience with the injectable development is must have
• Hands-on experience with the drug development process
• Working with testing or studies like (formulation robustness
• Manipulate a formulation by changing the PH
• A lot of lyophilization mapping
• Evaluation of the manufacturing process in scaling up
• Evaluating the manufacturing process for the ADC
• Looking for someone who has direct experience with stability studies for drug products and the analytical methods
• 60 to 70 lab work and 30 to 40 working with protocols and computer-based work
• PHD with 7 years of experience can be overqualified
• PHD with 0 to 1 years of experience will work
• Lyophilization experience is required
• Basic understanding Lyophilization process in the characterization methods for liftgates
• Support a scientist with lyophilization mapping studies
• Solid background in Lyophilization process and characterization
• If the candidate is not having ADC experience, then General biologics experience will work

What are the top 3-5 skills, experience or education required for this position:

• Bachelor’s Degree, or equivalent education, with typically 7 or more years’ experience or Master’s degree or equivalent education with 3 years’ experience in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or similar area.(PhD with 0+ years' experience acceptable).
• Supporting the process development of parenteral drug products with a focus on antibody drug conjugates (ADCs).
• Design and execute studies evaluating the stability (chemical & physical) of biologics against solution conditions (pH, ionic strength, temperature, light, moisture, etc.) and physical stresses arising from manufacturing process conditions (freeze thaw, mixing, filtration, filling, and lyophilization), to develop robust dosage forms.
• Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
• Demonstrated scientific writing skills and strong verbal communication skills.

Job Description

• Product Development Science and Technology (PDS&T) is seeking a motivated Scientist, specifically for parenteral drug product process development and commercial site scale up and tech transfer.
• The candidate will independently design and execute lab studies to develop robust manufacturing processes for clinical phase and commercial products.
• This person will generate and analyze precise, reliable, and reproducible data in a timely manner, independently or under the direction of a more senior scientific leader. This position will be an integral part of the product development and CMC teams.