Sivakumar Chinniah M.S,Mba., Email & Phone Number

New York, Ny, Us

Cranbury, New Jersey, Us

CMIC headquartered in Tokyo, Japan is a global CDMO/CRO organization with a significant presence in Southeast Asia. CMIC has an R&D center and 4 manufacturing plants in Japan and one in South Korea. CMIC CMO USA(CCU) the US subsidiary of CMIC has been engaged in CDMO activities since 2007. CMIC recently acquired a 235,000 SFT facility in Cranbury, NJ. The site is approved for the manufacturing and packaging Oral solid dosage forms. CCU provides services from pre-clinical, generic product development, and Phase 1 through commercial manufacturing.Working towards the turnaround of the business

Provide Consulation and advisory services in the areas of 01. Business strategy 02. Organization positioning03. Startup plans and execution04. Designing and creation of Pharmaceutical R&D, Manufacturing facility05. Preparing the facility for FDA inspection and approval06 .Product development strategies07. Enhancement of FDA compliance 08. FDA compliance remediation09. Change management10. Improving the organzation efficiency11. Improving the Top line and bottom line of the business

Sterling is a family-owned $70M active pharmaceuticals ingredients company. Sterling is a pioneer in corticosteroids with two manufacturing plants in Italy/Malta. Products are sold in the US, Europe, and IndiaPresident- Business Excellence- Sterling SPA, Italy Appointed to expand the business globally with the focus on finished dosage business (dermatology) in USA. Developed R&D capabilities and FDF manufacturing strategies. Identified product mix to maximize profits, partnered with a marketing company, and created business plans to raise money from PE investors in Italy

Hyderabad, Telangana State, In

MSN Pharma is owned by MSN Labs, a research-based pharmaceutical company based in India. $500M sales. The company has filed 350+ global and domestic patent applications and owns a portfolio of 300+ APIs and 200 product formulations in multiple therapeutic categoriesRecruited to startup a new organization in the US, larger scale than previous company and reported to Chairman in India. Led Research, Manufacturing, Sales Operations, and Supply chain division in the US. Created and executed viable strategies for US generics business. Built an HR infrastructure in the US with a strong cohesive team that played a key role in rapid growth.Business Strategy & Business Development• Developed and executed the business strategy encompassing contract manufacturing Y1 revenue forecasts of $20M. • Created and implemented strategies for MSN US Operations. Developed CDMO partners.Research & Development• Led a lean team of 15 to launch product development in October 2018, developed and manufactured submission batches of 9 products between April and October 2019 with lean manpower, and filed first abbreviated new drug application (ANDA) in Feb 2020. • Filed 6 ANDAs by June 2020 that were accepted by FDA without RTR and ~5 more products ready for filing. • Developed 15 products that are para IV,505(b)2, and Part III.Manufacturing, Supply Chain, Quality, and Plant Construction• Designed, obtained approvals, and completed the construction activities of the pilot plant in 5 months and started development activities 3 months later. Constructed commercial manufacturing plant within 9 months.• Managed business utilizing Agile Methodologies under tight cost control. Established manufacturing and quality systems and the Plant was made ready for FDA inspection.• Built the material management system and developed a vendor base of 200+ for all materials and services.

East Windsor Township, New Jersey, Us

Startup generic pharmaceutical company focused on development and manufacturing of ANDAs that includes tablets, capsules, liquids, and powder for suspension. ANI Pharmaceuticals acquired for Novitium for $200M in 2019.Identified a market need for products that would be necessary in a competitive market. Head of Manufacturing, Supply Chain, Product development, and Site Manager. Co-founded the company and created an R&D facility within 3 months. Designed and oversaw the construction of a commercial manufacturing facility. Recruited a team, created infrastructure and developed a strategy for business and manufacturing. Obtained FDA approved and created ~$60M revenue pipeline. Laid foundation for successful exit.

Parsippany, Nj, Us

Wockhardt is a $1.2B global pharmaceutical and biotechnology company headquartered in India with 14 manufacturing plants in India, Ireland, the UK, France, and the U.S.Relocated to the U.S. with the title of VP-Operations & Reorganization to turn around a facility that was operating at an $18M annual loss and had significant issues with the FDA. Led the Morton Grove Operations while also serving as Site General Manager, a Member of the Board, and as a member of the company’s Corporate Governance Board (Corporate Strategy Planning Committee). Served as a member of the New Product Identification Team that projected and analyzed the future market value of generic products. Led 6 FDA inspections.P&L• Led turnaround from an $18M annual loss to $12M profit in one year. Supported the growth and increased the gross profit to $65M for the sales revenue of $145M in 5 years.M&A• Played a key role in the acquisition and integration of a company that manufactures Liquid and Nasal spray products. Transformation Management• Created a cohesive leadership team and aligned them with company goals. Recruited 4 high-performing executives who have helped to transform the business.• Improved employee morale by building a strong team environment and enlisting employee input to improve product quality and to achieve FDA compliance.Business Strategy• Contributed to long-term global business strategy as a member of the Corporate Strategy Planning Committee that meets regularly with the Global Executive Team. • Created an outsourcing business strategy for OTC drugs to increase top-line growth; previously the organization had focused exclusively on prescription drugs. This strategy is projected to increase revenue up to 25% over the next 5 years.• Successful turnaround of the business has been developed into a case study at Northwestern University’s Kellogg Graduate School of Management. Selected to teach the strategy/execution to Kellogg students.

Mumbai, In

Recruited to a $400 million company to grow the manufacturing business and to reduce the use of contract manufacturing accounts to improve bottom-line revenue. Identified as a high performing employee and was selected to relocate to the U.S. to lead a large operation.- Managed multiple manufacturing locations that manufacture all dosage forms- Managed over 50 contract manufacturing locations- Oversaw the construction of a large manufacturing site, qualified, commissioned, and launched the manufacturing of over 40 products within a year- Managed the manufacturing site acquired in Ireland- Created significant value in terms of the bottom line and supported the top-line growth

Hired to drive change and to create/implement FDA compliant processes so that IND-Swift could begin exporting products to the U.S.► Directed all operations with P&L responsibility for three manufacturing plants including production, quality, warehouse & distribution, global sourcing, planning & forecasting, human resources, accounting, and finance.► Designed and built a fourth manufacturing plant.► Led the organization through change management and provided leadership towards global thinking.

Chennai, Tamil Nadu, In

Hired to a $15 million early-stage start-up company as executive assistant to senior vice President to coordinate R&D programs, develop the R&D lab, and create manufacturing strategy. Promoted as General manager to design, build, and run two manufacturing plants. Managed all functions of two plants with 300 employee► Directed all operations for two tablet, capsule, and dry syrup manufacturing plants including warehouse, distribution, human resources, accounting, finance, and quality.► Managed the outsourcing of formulations from third parties.► Played a key role in growing their formulations business from $2M to $15M in 2 years► Designed and developed their state-of-the-art manufacturing plant for the US market along with Land Lease consultants from the UK. Part of this plant and the business was purchased by Hospira Inc in 2011.

Bangalore, Karnataka, In

Hired as a site supervisor for a $1 million start-up company. Commissioned and qualified two sterile manufacturing plants. Created a strong team and developed them to support the dynamic growth of the organization. The company grew to $40 million in sales(of contract manufacturing income) in 4 years of my employment. Managed the manufacturing of sterile injections with 220 employees.

Cambridge, Cambridgeshire, Gb

Joined with the organization during its initial stage and was involved in the commissioning, validation, and commercial manufacturing of the finished dosage form facility. Managed sterile injections, tablets, capsules, creams, and ointment manufacturing. Played a key role in obtaining ISO certification.

Business Administration And Management

Ms-Regulatory&Quality Compliance, Regulatory And Quality

Mba, Business Administration And Management

Bachelors In Pharmacy, Pharmacy

Certificate Program, Six Sigma