Amar K Jain, PMP® Email: adwkg4@r.postjobfree.com

*** ************** *** **** **: 973-***-****

Monmouth Junction, NJ; 08852

SUMMARY

Over 15+ years of experience with thorough knowledge of Pharmaceutical Industry.

PMP Certified.

Expertise in Product life cycle from Product Development through to Commercialization.

Expertise in managing Projects with large teams using PMBOK® methodology, Agile, Scrum and Waterfall.

Expertise in managing budget in millions and forecasting.

Excellent in strategic planning and cross functional team integration.

Excellent in providing solutions for quality management system, business development, alliance partnerships, contract negotiations and portfolio management.

Expertise in implementing and maintaining the Quality Systems.

Expert in root cause analysis and risk management.

Experience in utilizing various chromatographic and spectroscopic analytical instruments such as HPLC, GC, UPLC, particle size instrument, IR, UV/VIS spectrophotometer

Excellent knowledge of FDA/Regulatory guidelines.

Knowledge of supply chain process.

Knowledge of Software Lifecycle Development.

Working Knowledge in SAP, Empower, Chromoleon, LIMS, MS Project Enterprise Systems.

ACHEIVEMENTS

Led cross-functional sites to execute and implement projects achieving high Manufacturing Success Rate and reduce Through Put Time for Kymriah.

Implementation of Quality Systems for New Manufacturing Facility.

Execute New Product Launches.

Led the cross functional teams for ANDA/BLA/ 505b(2) filings.

Managed project teams for technology transfer activities.

Helped achieve increase in revenue by 10% by strategically planning and applying six sigma principles.

Led project teams onsite and offshore (total of 20 core team members) in implementation of SAP – Rollout in 6 months.

Migration from Empower-3 to Empower-3FR3 Server.

WORK EXPERIENCE

Hikma Pharmaceuticals, Berkeley Heights, NJ October 2021 – Present

Sr. Project Manager – External R&D

Lead complex R&D injectable products including developing project scope, timelines, and resource requirements in collaboration with the cross functional teams and external partners.

Working with external partners on complex injectable products to drive timely completion of the development activities as well as timely submission of the eCTD file to the US

Lead cross-functional project teams to adhere to key project timeline milestones, risk management analysis, key transfer dates and overall project and business goals.

Help resolve technical challenges with the API suppliers, internal team members, as well as 3rd party labs and external partners using project management tools and processes.

Identify critical paths and barriers.

Deliver implementation strategies and resolve issues impacting them.

Proactively manage projects, anticipating issues and potential delays to achieve on-time completion.

Organize and lead regular project review meetings with cross-functional departments.

Issue meeting minutes and capture decisions and action items.

Prepare and manage the project risk register and for making decisions regarding the appropriate risk when there is substantial project impact.

Escalate issues/critical events and facilitate prompt attention/resolution.

Provide input to project prioritization process.

BlueBird Bio, Boston, MA June 2021 – October 2021

Project Manager – QC CTO Manager

Plan, direct, and coordinate activities of our Quality Control (QC) Testing Laboratories, providing strategic alignment and support to our Contract Testing Organizations (CTOs).

Provide solutions and visibility across our Quality functions, formulate quality control policies, and control quality of laboratory and production efforts.

Manage QC communications within CTOs and planning/leading CTO team meetings and building strong relationships

Monitor CTO capacity, identify constraints, coordinate testing priorities, and offer proactive solutions while providing status updates to and liaising between internal and external stakeholders

Support inventory management and supply chain activities

Manage KPIs while providing periodic updates to management as well as manage PO accruals, quotes, invoices and forecasting

Support CTO establishment and strategic planning (i.e. Quality Agreements, turnaround times, vendor qualifications; leading Quality Agreement implementation/revisions and supporting Health Authority filings

Manage audit readiness activities.

Novartis Pharmaceuticals, East Hanover, NJ December 2018 – June 2021

Global Project Manager

Technical Project Management:

Responsible for project which includes scope setting, roadmap developing and report building

Support CGTDM project portfolio with setting scope, objectives, deliverables, monitoring timelines and project organization against priorities according to business importance and impact

Lead the overall execution of multiple technical projects regarding initiation, budgeting, scheduling, monitoring, and closure according to GMP, safety and environmental requirements.

Provide input to the overall program strategy for key projects and cross-functional teams

Act as PMO member of designated broad scope projects/programs

Ensure necessary communication within the project teams (meetings, minutes, action items) and coordinates interfacing with other departments

Write and execute technical documents/reports in support of project execution

Nominate the project team together with the project champion/customer and involved line management

Coordinate internal resources and third parties/vendors for the flawless execution of projects

Manage project risks and strategic influencing to maintaining project timelines

Create and maintain comprehensive project documentation

Leadership Meeting and Monthly Status Reporting:

Responsible for weekly and monthly reports by partnering with all the stakeholders to collect and analyze data and structure weekly/monthly report for final submission

Work with leadership team to build meeting agenda and structure meeting deck

Follow up and track status of all the actions coming from leadership meetings

Support global matrix (performance) reporting processes by working with key stakeholders to translate data to scorecard (performance tracker).

Lupin Pharmaceuticals (previously Novel Laboratories Inc.), Somerset, NJ September 2009 – December 2018

Project Manager (July 2016 - December 2018)

Managed ANDA filings, New Product Launches and Technology Transfer projects.

Developed project charter, scope, schedule, milestones and deliverables.

Developed and built the project teams.

Led cross functional teams to ensure successful implementation, management and completion of product launch.

Provided guidance to teams and execution of strategic plans.

Identified project risks and risk owner.

Ensured effective communication within and external to the team.

Collaborated with functional heads to ensure it was fully resourced.

Planned and managed the budget.

Monitored and controlled the timeline.

Reported accurate project status and escalated issues necessary when not resolved within the team.

Monitored team performance regularly.

Resolved conflicts within the team.

Led, motivated and managed project management team and project team throughout the project life cycle.

Developed and managed KPIs to drive improvements to gain efficiencies and deliver performance.

Prepared Dashboards and Stage Gate documentation and presented to the senior leadership team.

QA Compliance Supervisor (June 2013 - July 2016)

Led, reviewed and approved investigations.

Performed quality system implementation.

Reviewed and approved SOP’s.

Identified relevant quality related training and delivered training to all personnel.

Performed regular internal audits, recommended changes, and initiated corrective and preventive actions when appropriate.

Performed external audits as required.

Monitored the effectiveness of CAPA.

Reviewed and approved the change controls.

Reviewed and approved process and analytical validation protocols.

Reviewed and approved specifications, analytical methods and master batch records.

Reviewed and approved Annual Product Reviews.

Participated in FDA Audits.

Reviewed and approved IQ, OQ and PQ documents.

Ensured the facility was in cGMP compliance.

Analytical R&D Scientist (September 2009 - June 2013)

Researched and developed qualitative and quantitative analytical methods for various dosage forms such as solids, semi-solids, solutions, suspension, inhalations, creams, ointments, topical oil and solution.

Performed analytical method validation for active drug substances and finished Products.

Prepared and reviewed technical reports, analytical test methods and specifications for various active drug substances, intermediates and finished products.

Prepared and reviewed analytical method validation protocols, method transfer protocols and validation reports.

Conducted analytical investigations.

Reviewed analytical data and lab documents.

Trained junior chemists and led a validation group.

Compiled stability data and prepared CMC documents for regulatory filing ANDA’s.

Prepared annual product reports.

Troubleshot various analytical equipment’s.

Monitored the compliance of the lab.

Prepared, reviewed and revised the SOP’s.

Accumed Inc., Lawrenceville, NJ July 2008 – September 2009

QA Specialist

Prepared, issued and reviewed manufacturing and packaging batch records.

Revised and prepared SOP’s

Prepared validation reports, stability reports and packaging validation reports

Maintained documentation involving change controls, deviations, incident reports, rejected batch records, control sample room, and calibration of balances

Final release of finished products.

Audited production shop floor, issued audit reports, and approved responses

Investigated market complaints

Developed and implemented training materials for QA personnel and manufacturing personnel.

Evaluated internally rejected material and determined an appropriate disposition.

Reviewed protocols for cleaning validation and process validation protocols

EDUCATION

Fairleigh Dickinson University, Madison, NJ

Master of Science in Chemistry with Pharmaceutical Concentration

December 2008 - G.P.A: 3.9

Andhra University, Vishakhapatnam, India

Bachelor of Science in Pharmacy

May 2006 - G.P.A: 3.8

COMPUTER SKILLS:

Proficient in MS Project, Word, Excel, PowerPoint, SAP software, Empower and Chromeleon software.

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