9 jobs in Biocon Biologics

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have proven end to end expertise in the field of biosimilars, from its development, manufacturing, clinical development, regulatory approvals to commercialization. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

KEY RESPONSIBILITIES

• Own end-to-end IT leadership for the Pharma Manufacturing & R&D Sites covering IT Operations, Digital Manufacturing, Automation, Smart Labs and OT systems.
• Act as the primary technology partner to Site Leadership, Manufacturing, R&D, and Engineering teams.
• Drive Industry 4.0, Smart Factory, Smart Labs, and IoT initiatives across shop-floor, labs, warehouses and utilities.
• Ensure reliable, secure and compliant operation of core manufacturing systems including MES, LIMS, DCS, SCADA, Historian and Serialization.
• Lead digital transformation programs focused on predictive maintenance, real-time analytics, AI/ML use cases and paperless manufacturing.
• Ensure full compliance with GxP, Data Integrity (ALCOA+), CSV, and regulatory expectations (USFDA, EMA, MHRA, etc.).
• Manage site IT budgets, vendors, system integrators and technology partners.
• Build and mentor high-performing site IT and automation teams with strong succession planning.
• Collaborate with Global IT, Architecture and Digital teams to align site initiatives with enterprise standards.

YEAR ONE CRITICAL SUCCESS FACTORS

• Stabilize and standardize all critical manufacturing and R&D systems at the site.
• Define a Digital roadmap for Manufacturing & R&D IT inline with functional goals and strategies.
• Deliver at least 3–5 high-impact Industry 4.0 / IoT use cases with measurable business value.
• Leverage use of AI and ML in Batch manufacturing, automation and predictive maintenance.
• Improve system availability, data integrity and audit readiness across the site.
• Establish a robust IT/OT governance framework with high security.
• Build strong credibility and trust with Site Leadership and Global IT stakeholders.

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

• Bachelor’s or Master’s degree in Engineering, Technology or related discipline.
• 22+ years of experience leveraging Information Technology, Digital, IoT and Industry 4.0 in large-scale manufacturing environments.
• Minimum 10+ years in Pharma / Life Sciences manufacturing with strong exposure to regulated systems.
• Proven leadership experience managing complex IT, Automation and OT landscapes at manufacturing sites.
• Deep understanding of MES, DCS, SCADA, LIMS, Historian, Serialization and Cloud-based analytics platforms.
• Strong experience in regulatory inspections, audits and remediation programs.
• Excellent stakeholder management, communication and executive presence.
• Ability to operate strategically while remaining hands-on when required in a plant environment.

Role Purpose

Lead end-to-end Generics (Drug substance and Drug product) development programs across R&D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.

Key Accountabilities

1. Program Governance & Execution

- Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.

- Drive governance forums and executive reporting

2. Budget & Financial Management

- Own program budget, forecasting, and cost optimization

- Deliver variance analysis and financial insights

3. Regulatory Strategy Alignment

- Align with FDA, EMA, and global Generics (Drug substance and Drug product) guidelines

- Support filing strategy and lifecycle management

4. R&D and Clinical Oversight

- Coordinate development, strategy discussions, clinical studies execution etc.

- Manage CRO and CMO engagements and timelines, as may be necessary.

5. Stakeholder Management

- Lead cross-functional alignment across internal and external partners

- Manage CMOs/CROs and contractual deliverables

6. Risk & Decision Management

- Identify risks and implement mitigation strategies

- Enable data-driven decision making

Education & Experience

- Master’s / PhD in Life Sciences in / Biotechnology / Pharmacy

- PMP preferred

- 8–15+ years in biopharmaceutical industry

- Demonstrated experience in Generics (Drug substance and Drug product) development programs

Competencies

- Advanced program and financial management skills

- Strong understanding of Generics (Drug substance and Drug product) regulatory pathways (US/EU)

- Cross-functional leadership and stakeholder management

- Excellent communication and influencing skills

- Strategic thinking and problem solving

Department: Manufacturing (DP - Fill Finish)

Title: Internship

Tenure: 6 Months

Working Days: 5-6 Days a week (based on Business Requirements)

Education: MA, BA, MSC, M. Tech and PHD (Stipend depends on qualification and tier)

Core Skil

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• esResearch Skil ls – Strong capability to gather, verify, and analyze informati
• onEditing & Proofreadi ng – Ensuring accuracy, grammar, and clarity in conte
• ntStorytelli ng – Presenting information in a compelling and reader-friendly mann

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Communication Ski

• llsExcellent Written Communicat ion – Clear articulation of ideas and narrati
• vesInterviewing Ski lls – Ability to extract information from sources effectiv
• elyPublic Relations Awaren ess – Understanding of audience and media t

one
Analytical Sk

• illsCritical Thin king – Evaluating facts and presenting balanced viewpo
• intsAttention to De tail – Ensuring factual correctness and consist

ency
Technical S

• killsKnowledge of Publication Stan dards – Familiarity with editorial guidelines and fo
• rmatsSEO/Content Optimization (if applic able) – Writing content suitable for digital
• reachMS Office / Content Tools – Basic tools for drafting and ed

iting
Professional

• SkillsTime Mana gement – Meeting deadlines consis
• tentlyAdapta bility – Writing across different topics and cate
• goriesEthical Journalism Pra ctices – Maintaining credibility and int

egrity
Optional/Additional (if re

• levant)Photography or Multimedia
• SkillsSocial Media Content Pr
• omotionLanguage Proficiency (Multiple Lan

Role description

Lead tracking & reporting of end-to-end execution of generics manufacturing and quality programs for commercial manufacturing. Drive cross-functional coordination to ensure timely delivery, regulatory compliance, product quality, supply continuity, and successful commercialization of generic pharmaceutical products.

Key Responsibilities

1. Program Management

• Develop and maintain integrated trackers, milestones, timelines, budgets, and governance dashboards.
• Track progress and ensure on-time delivery of key manufacturing, quality, regulatory, and supply chain deliverables.
• Lead operations reviews and provide management updates on risks, opportunities, and mitigation plans.
• Drive accountability across cross-functional teams to achieve project objectives.

2. Quality & Compliance

• Partner with Quality teams to ensure compliance with GMP, regulatory requirements, and company quality standards.
• Oversee project-related deviations, CAPAs, change controls, investigations, and quality risk management activities.

3. Cross-functional Leadership

• Collaborate with Manufacturing, QA, QC, Regulatory Affairs, MSAT, Supply Chain, Procurement, R&D, and External Manufacturing teams.
• Facilitate decision-making and issue resolution among stakeholders.
• Drive alignment across global and regional teams to meet business priorities.

4. Risk & Stakeholder Management

• Identify project risks and develop mitigation strategies.
• Escalate critical issues proactively and drive timely resolutions.
• Manage communication with senior leadership and present project progress, challenges, and recommendations.

Qualifications & Experience

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Life Sciences, Chemical Engineering, or related discipline.
• 8–15 years of experience in pharmaceutical manufacturing, quality, technical operations, program management, or related functions.
• Proven experience managing complex pharmaceutical projects, preferably in generics manufacturing and commercialization.
• Strong understanding of GMP, regulatory requirements, technology transfer, validation, and quality systems.

Key Competencies

• Program & Portfolio Management
• Manufacturing Operations
• Quality Systems & Compliance
• Risk Management
• Regulatory Knowledge
• Leadership & Influencing Skills
• Stakeholder Management
• Problem Solving & Decision Making
• Executive Communication

Financial Reporting Role

BIOCON BIOLOGICS:

At Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking.

We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long-term commitment to bring high quality affordable biosimilars to patients all over the globe.

BACKGROUND AND EXPERIENCE REQUIRED:

Technical Skills:

- Strong accounting knowledge and familiarity with financial products.

- Lead audits, month and quarter close and lead key technical discussions

- Legal entity audit and compliances for ~35 legal entities across geographies

- Proficiency in MS Office applications (Excel, Word, PowerPoint).

- Ensure SEBI reporting and all compliances relating to LODR, FEMA and Companies Act

- Lead Capital market transactions for any fund raise and coordinate with bankers and lawyers

Behavioural Competencies:

- Strong communication skills.

- Ability to work with global teams across APAC and Paris time zones.

- Strong numeric aptitude with rigor and analytical thinking.

- Excellent organizational skills, deadline-oriented, hardworking, and a strong team player.

Qualifications & Experience:

- Chartered Accountant (CA) or equivalent qualification.

- 1-4 years of post-qualification experience in financial reporting, consolidation, and accounting, preferably within the Pharma/ FMCG/Biotech sector.

- Hands-on experience with ERP systems and reporting tools

- Demonstrated ability to build processes and teams from the ground up.

- Strong background in accounting principles.

- Often requires a bachelor's degree in finance or accounting, with advanced degrees preferred for senior role.

JOB DESCRIPTION:

Responsibilities:

- Prepare monthly financial reports for Head Office, including P&L, balance sheet, off-balance-sheet items, annexures, tax schedules, and regulatory reporting.

- Handle ad-hoc financial reporting requests from Head Office.

- Execute controls and analytical reviews as outlined in the BNP Paribas Standard Accounting Control Plan.

- Manage inter-company reconciliation and resolve Interco breaks.

- Participate in Finance projects related to Head Office reporting.

- Coordinate effectively with the Regional Financial Reporting team during pre-closing activities and for resolving accounting matters.

- Work towards reducing manual reclassifications, addressing warnings or missing items, and resolving issues at the source.

- Provide timely, accurate, and complete financial data to the Reporting Team.

- Respond to queries raised by Head Office Finance, Regional Finance, and internal management.

- Support the Head of Department in leading, developing, and managing the team to ensure excellence in all departmental activities.

- Assist the HOD in ensuring smooth departmental operations, consistent service delivery, and effective motivation of team members.

Technical & Behavioral Competencies:

- Strong understanding of IFRS accounting standards.

- Solid knowledge of financial products.

- Proficiency with basic office tools (Lotus Notes, MS Word, Outlook).

- Advanced expertise in MS Excel.

- Strong communication and analytical skills.

- Effective stakeholder management abilities.

- High comfort working with numbers-precision, analytical mindset, and strong interpretive capability.

- Excellent organizational skills with the ability to prioritize and meet deadlines.

- Hardworking, collaborative, and team-oriented.

- Curious, adaptable, and open to diverse cultures.

Role-Clinical Data Manager

1. Evaluation of data management capabilities of CRO/vendors/service providers and due diligence.

2. Design of annotated CRF, EDC as per protocol requirement.

3. Manage all aspects of clinical data management such as query management, discrepancy management, UAT, Edit Check in development of EDC.

4. Creation, review, approval of data management documents for project set-up, conduct and close out phases.

5. Set KPIs and oversee the clinical data management deliverables of CROs/Vendors.

6. Ensure project team and CRO adhere to the timelines and deliverables.

7. Define data review requirements and processes to ensure delivery of highest quality data.

8. Review clinical study data/listings including TLFs.

9. Oversee and guide CRO during data base lock.

10. Set risk and mitigation plan for data management related deliverables.

11. Oversees Clinical data migration and reconciliation from one system to another system.

12. Keep abreast on new technologies available on holistic review of data and ways to improve efficiencies in data review to improve data quality.

13. Undertake SOP preparation/review required for clinical development.

14.12–13 years of overall experience in Clinical Data Management within sponsor and/or CRO environments.

Job description:

Clinical Project Manager

1. Proactively manages clinical trials from start-up to closure with a focus on trial timelines, quality, budget, and vendor oversight.

2. Leads selection of CRO and vendors including identification of potential vendors, RFP process, qualification of vendors where required and contract negotiation.

3. Supports preparation of regulatory dossier by providing documents and required information

4. Leads the study start-up process, including, but not limited to, preparation of the trial kick-off meeting, study documents, plans and manuals, set-up of the trial master file (TMF), and site feasibility process (where applicable).

5. Collaborates with the Clinical Trial Supply Management function to ensure an effective procurement and supply strategy for study medication, with no stockouts during trial and low overage at study end.

6. Oversees CRO and vendors during the trial to ensure compliance with project requirements, internal processes, timelines, budget, ICH GCP, and local and international laws.

7. Monitors the quality of vendor deliverables, addresses quality issues with the appropriate team members and identifies opportunities to improve training, execution and quality control.

8. Oversees monitoring of clinical trials, ensuring high-quality trial execution at sites, identification of deviations and implementation of mitigation strategies as required.

9. Ensures study is at all times inspection ready.

10. Provides efficient updates on trial progress to Head of Clinical Operations and Senior Management.

11. Ensures trials are registered in trial registries (as applicable) and accuracy of trial information and that updates and final reporting are submitted on time.

12. Ensures timely shipment and tracking of lab samples to ensure no loss of samples due to lack of operational oversight and availability for timely analysis for study reporting.

13. Ensures risk management plans and contingency plans are available for assigned trials and escalates key study risks to the attention of the Head of Clinical Operations/Senior Management. 14. Reviews and approves vendor invoices in collaboration with the Development Finance Specialist/Finance department personnel to ensure vendor payments occur in a timely manner

15. Supports vendor and site audits, follows up on audit findings to ensure appropriate responses and CAPAs implemented by vendors and sites.

16. Ensures all project-level study documentation is filed in the TMF in accordance with applicable SOPs, guidance documents and regulatory requirements and provides oversight to the CRO team regarding TMF filing, maintenance and archival procedures.

17. Supports preparation of responses to queries from Regulatory, Marketing or any other molecule related queries.

18. Ensures at study end that eTMF is completed and archived, budget reconciled, lab samples and IMP samples retained or discarded as per internal decisions.

19. Supports SOP development and review, participates in internal process improvement activities and other activities as needed.

Role Purpose

Lead end-to-end Injectable (Drug- Device Combination) development programs across R&D, Clinical, Regulatory, and Manufacturing. Ensure delivery aligned to cost, timelines, and global regulatory expectations for advanced markets.

Key Accountabilities

1. Program Governance & Execution

- Lead integrated program planning across CMC, device management, clinical, regulatory, and supply chain.

- Drive governance forums and executive reporting

2. Budget & Financial Management

- Own program budget, forecasting, and cost optimization

- Deliver variance analysis and financial insights

3. Regulatory Strategy Alignment

- Align with FDA, EMA, and global Injectable (Drug- Device Combination) guidelines

- Support filing strategy and lifecycle management

4. R&D and Clinical Oversight

- Coordinate development, strategy discussions, clinical studies execution etc.

- Manage CRO and CMO engagements and timelines, as may be necessary.

5. Stakeholder Management

- Lead cross-functional alignment across internal and external partners

- Manage CMOs/CROs and contractual deliverables

6. Risk & Decision Management

- Identify risks and implement mitigation strategies

- Enable data-driven decision making

Education & Experience

- Master’s / PhD in Life Sciences in / Biotechnology / Pharmacy

- PMP preferred

- 8–15+ years in biopharmaceutical industry

- Demonstrated experience in Injectable (Drug- Device Combination) development programs

Competencies

- Advanced program and financial management skills

- Strong understanding of Injectable (Drug- Device Combination) regulatory pathways (US/EU)

- Cross-functional leadership and stakeholder management

- Excellent communication and influencing skills

- Strategic thinking and problem solving