Scientist 3, Process Development

Title: Scientist 3 Process Development
Location: Onsite Cambridge MA 02142
Duration: 6 Months with Potential Contract to FTE position
Pay Rate: $55.38/hr on W2

Summary:

• We are seeking a highly motivated and creative individual with some process development experience to join our Oligonucleotide/Peptide Purification Development team.
• This position provides an exciting opportunity to develop robust high purity state of the art processes for the purification of oligonucleotides.
• This position provides an exciting opportunity to gain hands-on experience and exposure to the design and development of manufacturing processes for clinical and commercial therapeutics.
• We are looking for someone who is passionate for exploring Client scientific ideas and play a key role in developing new cutting-edge technologies with a vision to push Clients state-of-art science in oligonucleotide and peptide purification that can ultimately impact patient lives.

Job Description:

• This role in the oligonucleotide development modality is responsible for purification development including process development process characterization scale-up for all unit operations (chromatography detritylation UF/DF) with some guidance.
• This position is expected to learn our oligonucleotide platform and develop our peptide platform while exploring non-platform and Client purification steps. They should have knowledge of the manufacturing facilities and equipment contribute to tech transfer activities document review provide on-the-manufacturing floor support troubleshooting and authoring CMC section of INDs.
• These activities can include early and late-stage process characterization and robustness studies.
• This position will act as a subject matter expert on purification processes to facilitate interactions internally within the oligonucleotide organization (synthesis drug product analytical) as well as cross functionally (with Research/Manufacturing/MS project and tech transfer teams).
• The ability to write development reports training/mentoring of new employees lead pilot scale activities and collaborate across teams or lead small focused initiatives are important. Some independent work is expected (e.g. root cause investigations evaluation of processes) with some guidance from the supervisor.

Responsibilities:

• Develop and characterize purification processes for a rapidly expanding pipeline of new oligonucleotides and peptide drug therapies. The individual will utilize multiple modes of chromatography and ultrafiltration and learn chemical cleavage/conjugation/hybridization steps.
• Investigate new purification technologies that seek to enhance purity process robustness and/or productivity of our existing oligonucleotide platform process.
• Collaborate cross-functionally with other groups to improve process understanding and manage team activities.
• Document laboratory work in development reports training/mentoring of new employees and lead pilot scale activities.
• Scale-up and technology transfer oligonucleotide processes into our pilot and GMP manufacturing facilities and participate in writing regulatory sections for INDs.

Qualifications:

• Proven record of successfully planning and executing projects and experiments.
• Excellent verbal and written communication skills. Demonstrated technical proficiency and creativity in developing innovative technologies/approaches in purification. Excellent organizational communication and time management skills.
• Lab experience in purification of proteins peptides and/or DNA/RNA using column chromatography (e.g. Ion exchange Hydrophobic Interaction and/or Reversed phase) and UF/DF.
• Some hands-on experience in analysis of proteins peptides or DNA/RNA preferably using both HPLC and UV/Vis spectroscopy. Experience using AKTA purification systems and Unicorn software and use of statistical design (DoE) are a plus. Experience in statistical analysis is also a plus.
• Motivated to work and communicate both individually and within teams

Education:
Associate Scientist 3/Engineer 2:
Bachelors degree in Biochemistry Chemical Engineering Chemistry or related life science field with 2-4 years industry experience (or masters degree with 0-2 years of industry experience) is required.
Senior Associate Scientist:
Bachelors degree in Biochemistry Chemical Engineering Chemistry or related life science field with 4 years industry experience (or masters degree with 2 years of industry experience) is required.

Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

Required Experience:

IC