Lead / Manager – Downstream Process Development (Biosimilars)

StrainX Biotech; India; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Biopatrika in India seeks a senior, hands-on Team Lead/Manager to head our Downstream Process Development for biosimilars. You will guide a skilled team, shaping scalable downstream strategies and delivering robust processes for complex therapeutics.

The role requires deep knowledge of protein chemistry, refolding, and chromatography (IEX/HIC/GF/RP) with hands-on experience on ÄKTA systems. Strong leadership and cross-functional collaboration are essential.

Qualifications

• Experience in biopharmaceutical R&D, specifically downstream process development for biosimilars.
• Strong knowledge of physicochemical properties of proteins and protein chemistry.
• Hands-on protein refolding from inclusion bodies experience.
• Understanding resin chemistries for IEX, HIC, GF and RP chromatography.
• Hands-on experience with ÄKTA systems and XK, HiScale and BPG columns.
• Ability to design scalable downstream processes for diverse protein therapeutics.
• Experience with large molecules (mAbs), growth factors, enzymes, insulins or GLP-1 analogues.
• Familiarity with DS/DP testing and ICH guidelines.
• Experience leading cross-functional teams (Upstream, QC, QA, Regulatory).

Responsibilities

• Lead the Downstream Process Development team for biosimilars.
• Design scalable downstream processes for various protein therapeutics.
• Collaborate with Upstream, QC, QA and Regulatory teams.
• Ensure robust data recording, storage and documentation (SOPs, STPs, BMRs).
• Mentor and train team toward company biosimilar goals.

Skills

Downstream process development

Protein refolding

Protein chemistry

Chromatography (IEX, HIC, GF, RP)

ÄKTA systems

Team leadership

Process scale-up

mAbs experience

Education

MSc/MTech in Life Sciences

PhD in Life Sciences

Tools

ÄKTA systems

XK columns

HiScale columns

BPG columns

Job description

We’re Hiring: Team Lead / Manager - Downstream Process Development (Biosimilars)

We are looking for an experienced and highly motivated professional to lead our Downstream Process Development team for biosimilars. This is a senior, hands‑on role for candidates with proven industry experience. Please review the requirements carefully before applying.

QUALIFICATION & EXPERIENCE

• M.Sc./MTech. in Life Sciences with a minimum of 10 years of experience, OR
• PhD with a minimum of 5 years of experience

MANDATORY REQUIREMENTS

• Have worked in biopharmaceutical industry R&D, specifically in downstream process development of biosimilars
• Have excellent knowledge of the physicochemical properties of proteins and protein chemistry
• Have proven, hands‑on industry experience in protein refolding from inclusion bodies
• Have a strong understanding of resin chemistries for IEX, HIC, GF and RP chromatography
• Have hands‑on experience with ÄKTA systems and XK, HiScale and BPG columns
• Be capable of independently designing scalable downstream processes for different types of protein therapeutics
• Have developed or contributed to downstream processes for:
  • Large molecules such as monoclonal antibodies (mAbs)
  • Medium‑sized molecules such as growth factors and enzymes
  • Small peptide‑like proteins such as insulins and GLP‑1 analogues
• Be familiar with in-process, drug substance (DS) and drug product (DP) testing
• Be familiar with ICH guidelines
• Have an excellent understanding of data recording, data storage and documentation, including preparation of SOPs, STPs, BMRs and other technical documents
• Have the ability to train and lead a team towards the company’s strategic goals in biosimilar development
• Have experience working with cross‑functional teams, including Upstream, QC, QA and Regulatory Affairs

PLEASE NOTE Theoretical knowledge of protein refolding and chromatographic principles alone will not make a candidate eligible. Real, hands‑on working experience in an industry setting is essential. Applications not meeting these criteria will not be considered.