Sivakumar Chinniah M.S,Mba.,

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

Chief Operating Officer and Board Member @ CMIC CMO USA
New York, NY, US
Sivakumar Chinniah M.S,Mba.,'s Location
New York City Metropolitan Area, United States, United States
Sivakumar Chinniah M.S,Mba.,'s Contact Details

Sivakumar Chinniah M.S,Mba., work email

Sivakumar Chinniah M.S,Mba., personal email

n/a
About Sivakumar Chinniah M.S,Mba.,

• Senior Pharmaceutical Executive with extensive experience in INDs and Generics. Expertise at leading Finished Dosage Sales&Marketing, Operations, R&D, Manufacturing, FDA Drug Approval/Compliance, Supply Chain, Quality, Regulatory, Commerce, and Finance. Adept at leading companies to rapidly pivot in response to market needs.• Recognized as an authentic leader who demonstrates high integrity. Experienced at launching new businesses, P&L management, building Greenfield sites, and developing comprehensive/executable business strategies that support organizational transformation and talent development efforts for sustained year-over-year growth and profitability. • Skilled at growing early-stage start-ups to become large and profitable enterprises, and turning around underperforming businesses and quality constrained operations in publicly traded companies. Adept at investor communications in PE-backed companies through transactions and/exits. • Build and sustain high performing company cultures and develop employees to become future leaders within the industry. Lead with a focus on mission, results, ethics, and an unerring emphasis on inclusivity, idea generation, and mentorship. Skilled at identifying/cultivating talent and providing opportunities for professional growth in nimble organizations in which trust, and integrity are modeled and valued. Maximize profits and employee loyalty.• Research and manufacturing experience includes Liquid and Dry powder injections, BFS, Prefilled syringes, Tablets, Capsules, Nasal sprays, Oral liquids, PFOS, Creams & Ointments, and others. Managed over 15 FDA inspections. Designed and oversaw the construction of 7 manufacturing plantsSkilled at managing entire business cycle of CDMO/CMO of IND, Clinical operations and Generics.Shiv is passionate about empowering people and believes in authentic leadership.Significant Accomplishments- Played a leading role in the growth of Wockhardt's US business from $ 80M in 2007 to about $550M in 2013- Worked closely with the Sales team to provide excellent customer experience that led to winning the DIANA award from the Pharmaceutical wholesalers association- Hired and developed performing teams for 3 organizations that outperformed the industry standards- Designed and oversaw the construction of the manufacturing plant of MSN Pharma, NJ that wascompleted in 5 months.- Constructed commercial manufacturing facility, developed about 15 products, and filed 6 products with the FDA for MSN Pharma in a record time

Sivakumar Chinniah M.S,Mba.,'s Current Company Details
CMIC CMO USA

Cmic Cmo Usa

View
Chief Operating Officer and Board Member
New York, NY, US
Website:
cmiccmousa.com
Employees:
65
Sivakumar Chinniah M.S,Mba., Work Experience Details
  • Cmic Cmo Usa
    Chief Operating Officer And Board Member
    Cmic Cmo Usa
    New York, Ny, Us
    View
  • Cmic Cmo Usa
    Chief Operating Officer & Board Member
    Cmic Cmo Usa Jan 2024 - Present
    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
    View
  • Self-Employed
    Pharmaceutical Consultant
    Self-Employed Jul 2022 - Dec 2023
    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 S.P.A.
    Interim President
    Sterling S.P.A. Jul 2021 - Jul 2022
    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
    View
  • Msn Laboratories/Msn Pharmaceuticals Inc
    President
    Msn Laboratories/Msn Pharmaceuticals Inc Nov 2017 - Jun 2020
    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.
    View
  • Novitium Pharma Llc
    Vice President -Operations|Founding Member
    Novitium Pharma Llc Sep 2015 - Nov 2017
    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.
    View
  • Wockhardt Usa/Mortongrove Pharmaceuticals
    Vice President Operations, Supply Chain & Site Manager
    Wockhardt Usa/Mortongrove Pharmaceuticals Oct 2007 - Jan 2015
    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.
    View
  • Wockhardt
    Associate Vice President, Operations
    Wockhardt Jan 2005 - Oct 2007
    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
    View
  • Ind Swift
    Senior General Manager
    Ind Swift Jun 2003 - Dec 2004
    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.
    View
  • Orchid Pharma
    Site Director-Plant Manager
    Orchid Pharma Jun 1999 - Jun 2003
    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.
    View
  • Strides Arcolab Limited(Agila Specialities)
    Manufacturing Manager
    Strides Arcolab Limited(Agila Specialities) Jun 1995 - Jun 1999
    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.
    View
  • Astrazeneca-German Remedies
    Production Officer
    Astrazeneca-German Remedies Dec 1990 - Mar 1995
    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.
    View

Sivakumar Chinniah M.S,Mba., Skills

Leadership Six Sigma Team Building Research And Development Strategic Partnerships Lean Manufacturing Human Resources Executive Management People Management Gmp Global Sourcing Start Ups Pharmaceutical Manufacturing Good Manufacturing Practice Business Development Communication Regulatory Affairs Mentoring Six Sigma Black Belt Validation U.s. Food And Drug Administration Strategic Planning Medical Devices Lean Management Pharmaceutical Facility Design And Development Quality System Fda Inspections Operations Management Contract Manufacturing Profit Maximization Cross Functional Team Leadership Manufacturing Change Management Training Business Strategy Management Product Development Project Management Pharmaceutical Industry Technology Transfer P&l Financial Management Supply Chain Continuous Improvement Aseptic Processing Mergers And Acquisitions Strategic Sourcing

Sivakumar Chinniah M.S,Mba., Education Details

  • Northwestern University - Kellogg School Of Management
    Northwestern University - Kellogg School Of Management
    Business Administration And Management
  • Purdue University
    Purdue University
    Regulatory And Quality
  • Bharathidasan University, India
    Bharathidasan University, India
    Business Administration And Management
  • Madurai Medical College, India
    Madurai Medical College, India
    Pharmacy
  • University Of Illinois Urbana-Champaign
    University Of Illinois Urbana-Champaign
    Six Sigma

Frequently Asked Questions about Sivakumar Chinniah M.S,Mba.,

What company does Sivakumar Chinniah M.S,Mba., work for?

Sivakumar Chinniah M.S,Mba., works for Cmic Cmo Usa

What is Sivakumar Chinniah M.S,Mba.,'s role at the current company?

Sivakumar Chinniah M.S,Mba.,'s current role is Chief Operating Officer and Board Member.

What is Sivakumar Chinniah M.S,Mba.,'s email address?

Sivakumar Chinniah M.S,Mba.,'s email address is sc****@****ling.it

What schools did Sivakumar Chinniah M.S,Mba., attend?

Sivakumar Chinniah M.S,Mba., attended Northwestern University - Kellogg School Of Management, Purdue University, Bharathidasan University, India, Madurai Medical College, India, University Of Illinois Urbana-Champaign.

What skills is Sivakumar Chinniah M.S,Mba., known for?

Sivakumar Chinniah M.S,Mba., has skills like Leadership, Six Sigma, Team Building, Research And Development, Strategic Partnerships, Lean Manufacturing, Human Resources, Executive Management, People Management, Gmp, Global Sourcing, Start Ups.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.