Enzene Biosciences
Website:
enzene.com
Job details:
Job Title- SPS- PPD
Position Summary:
Senior Principal Scientist is accountable for the planning and execution of downstream-related multiple projects with moderate supervision. The individual reports to Associate Vice president/Assistant General Manager/ General Manager level Personal and will be responsible to manage team of up to 3-5 member. The Senior Principal Scientist is a highly motivated individual who has to work as department subject matter expert along with Project lead for the one or more individual project. He will be Accountable for project delivery through team members and mentoring of the team members like Scientist, SRA, Research Associate or intern level personals.
What You Will Do:
Sr. principal Scientist is responsible for but not limited to
- Planning and execution of Downstream Process activities for mammalian and/ or microbial products/recombinant protein along with team member under supervision of manager for multiple projects.
- Accountable for ground level planning, execution, data capturing, compilation, and interpretation in coordination with the reporting manager.
- Accountable reviewing of draft presentation and discussion with the help of team members.
- Attending and representing department in internal and external meetings as SME or as Functional Lead.
- Accountable for review/drafting of documentation activities like preparation of development reports, BPR, SOP, EOP, IOP.
- Accountable for planning and decision-making discussion regarding activity priorities provide information on the feasibility of prospective projects to reporting manager.
- Responsible for Troubleshooting of technical problems at manufacturing by discussion and execution.
- Sr Principal Scientist shall be accountable for lab management activities (Maintaining lab cleanliness, equipment maintenance etc.)
- Scientist is accountable for Cross-functional communication with internal and external vendors/clients for technical queries in consultation with reporting manager
- The candidate shall be Accountable for Maintain environment, health, and safety (EHS) requirements at workplace to ensure individual and lab/plant safety.
- Accountable for the GDP practices in team and lab
- Education, Experience & Other Requirements:
- M Tech/ M Sc with (13-21 Years) Ph D with (5-10 years of Experience) in the field of downstream process development
- Knowledge, Skills & Abilities:
- Excellent communication and presentation skills with multi-tasking ability
- Problem solving and Team Management skills,
- Good Documentation practice with ALCOA++ and experience to work in 21CFR compliant environment.
- Awareness related to safety practices in Biopharma labs
- Protein purification process development expertise and hands on experience with troubleshooting ability (Chromatography, Depth filtration, Centrifugation, UFDF, sterile filtration etc.) in mammalian/microbial expressed antibodies and/or therapeutic proteins.
- Accountable for the Execution and Monitoring of processes to ensure consistency and reliability.
- Experience in Process Development using Quality by Design (QbD), and DoE Based process development
- Hands on experience on data analytics using different statistical tools will be added advantage.
- Experience of Scale up/ Down, Technology Transfer (TT) activities and virus clearance (VCS) studies for multiple products.
- Accountable for the upkeeping the Lab in running state from equipment and compliance aspect. [Setup, operation, troubleshooting and routine maintenance of purification equipment’s (Chromatography system, pH/ conductivity meter, UFDF system etc)]
- Strong commitment and dedication towards work, enthusiasm, motivation, and persuasive ability in a team and experience of leading team of 1-2 members will be added advantage.
- Candidate should able to Work independently, analyse and interpret experimental data, and present/document experimental results at meetings.
- Proficiency about awareness in protein analytical techniques (e.g protein assay, gel electrophoresis, HPLC etc) is an added advantage.
- Willingness to work in a Dynamic, ambiguous environment with a timeline.
- Strong technical, organizational, and communication skills, as well as the ability to develop creative solutions to challenging problems.
- Proficiency in Process characterization and statistical data analysis
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