Full-Time
Validation Scientist
Piramal Pharma
1,001-5,000 employees
CDMO for drug development and manufacturing
No salary listed
Souderton, PA, USA
In Person
 Biology & Biotech (2) |
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- Minimum of a Bachelor's degree in a scientific discipline (e.g., Chemical Engineering, Pharmaceutics, Pharmacy, Chemistry or equivalent) with a minimum of 3 years experience in Technical Services, Process Engineering, Process Validation, Formulation or related field in the pharmaceutical industry.
- Experience in laboratory and production scale manufacture of solid oral, liquid and semi-solid dosage forms using equipment such as comminuting mills, high-shear granulators, fluid bed dryers, blenders, tablet presses, tablet film coaters, encapsulators, low and high-shear mixing vessels, homogenizers, pumps, packaging, etc.
- Working knowledge of cGMP (Current Good Manufacturing Practices) regulations, SUPAC guidances, and general compliance expectations.
- Working knowledge of investigational techniques, including but not limited to root cause analysis, risk assessment impact evaluation, and technical report writing.
- Must possess research and problem solving abilities and be capable of producing detailed documentation, understand and make generalized and specific conclusions from project data.
- Technical writing experience is required with attention to detail skills essential.
- Must be able to work in a team environment with effective project planning/management, analytical thinking, organization, and execution skills.
- Must have proficiency in the Microsoft Office Suite programs.
- Demonstrated professionalism and excellent communication skills with internal and external personnel are essential.
- Ability to work effectively managing multi projects at a fast pace with cross-functional departments and manage priorities to meet timelines.
- Must be innovative, proactive, resourceful and committed to continuous improvement.
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred.
- Lead and execute projects such as technology transfer, scale-up, process optimization process/packaging validation as well as equipment qualification and cleaning validation support to meet critical project deadlines.
- Provide technical support in the investigation of manufacturing incidents and major deviations. Assure thoroughness of investigation and documentation as well as implementation of preventive/corrective actions as necessary.
- Conduct commercial production technical support activities such as qualification of alternate suppliers of API, excipients and packaging components, equipment change parts, process parameters, yield limits, hold time studies, etc.
- Execute utility and process equipment qualification support activities such as installation, operational and performance qualifications, periodic reviews, investigations, assessments, review change control and non-routine maintenance requests, out of specification calibrations, etc.
- Perform cleaning validation support activities such as execution of cleaning validation and verification studies, hold time studies, investigations, assessments, justifications, maintain cross contamination program, etc.
- Develop and/or execute experimental designs and approaches to resolve technical problems and utilize engineering standards, concepts, equations as well as statistical techniques.
- Prepare and review documents to support projects, such as laboratory notebooks, protocols, reports, assessments, justifications, investigation reports, regulatory submissions, master batch records, change control, etc.
- Complete and document physical sampling and testing such as loss on drying, particle size distribution, bulk density, viscosity, pH, tablet weight, thickness, hardness and friability; sample for analytical and microbiological testing.
- Author and periodically update assigned Standard Operating Procedures (SOPs) for the department.
- Represent Technical Services at project team meetings and provide sound technical advice.
- Coordinate and interface with Operations, Facility Engineering, Quality Control, Quality Assurance and Regulatory Affairs groups to assure successful project execution.
- Directly interact with Piramal Pharma Solutions clients.
- Maintain regulatory compliance within the function and follow site safety, health, and environmental policies and procedures.
- Working knowledge of cGMP data management systems (EDMS, Trackwise, and/or SAP) is preferred
Piramal Pharma operates through three divisions: Piramal Pharma Solutions (PPS), a CDMO that provides development and manufacturing services across the drug lifecycle for clients worldwide; Piramal Critical Care (PCC), which produces complex hospital generics, including inhaled anesthetics; and the Consumer Products Division (CPD), selling consumer health brands in India such as Littles and Lacto Calamine. PPS supports drugs from development to production for customers; PCC makes hospital-grade generics; CPD distributes well-known Indian consumer health products. The company stands out with its global manufacturing scale, integrated network, and specialized strengths in complex hospital generics and inhaled anesthetics, alongside a strong portfolio of Indian consumer brands across more than 100 countries. Its goal is to grow its life-science ecosystem by expanding PPS and PCC capabilities and broadening CPD’s consumer brands across markets.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
India
Founded
2020
Simplify's Take
What believers are saying
- Kenalog acquisition from BMS adds $30-40M annual revenue via 6,000+ hospital network.
- ADCelerate program captures 80% biotech funding surge in H2 2024 for cancer therapies.
- Consumer Healthcare Power Brands grow 24% YoY with 48% e-commerce sales increase.
What critics are saying
- Lonza's US ADC expansions outpace Piramal's Riverview facility in 12-24 months.
- Chinese CDMOs like WuXi STA cut sterile injectables margins below 13% in 12-18 months.
- Inventory destocking contracts CDMO revenue 10% into FY27.
What makes Piramal Pharma unique
- Piramal Pharma Solutions delivers end-to-end CDMO services across drug lifecycle with 17 global facilities.
- Piramal Critical Care leads in inhaled anesthetics and complex hospital generics across 100+ countries.
- AbbVie JV dominates Indian ophthalmology market with glaucoma and dry eye treatments since 1996.
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Cleanroom flooring overhaul completed at Piramal Healthcare. A major cleanroom flooring overhaul has been completed at Piramal Healthcare Limited's Northumberland facility, with Kemtile replacing 650m^2 of pharmaceutical cleanroom floor in a 28-day installation programme. Cleanroom flooring replacement at Morpeth site. Piramal's Morpeth site is a fully integrated production facility offering Active Pharmaceutical Ingredients (APIs), oral solid drug product development, clinical supply, commercial manufacturing and packaging services for both innovator and generic pharmaceutical companies. The £250,000 flooring project marks a significant upgrade to the previous surface, which had been in place for 56 years. Kemtile, a division of international flooring manufacturer Stonhard, installed the new Stonhard GS flooring system, designed to deliver durability, chemical resistance and seamless hygiene suitable for pharmaceutical cleanroom environments. To enhance performance, Kemtile applied two coats of Stonkote HT4 with a textured finish to maximise slip resistance, and installed Polysto hygienic coving throughout alongside a new channel drain. Project delivery and industry collaboration. Kemtile's Jay Livingstone said: "It's built to meet the rigorous standards that Piramal's operations require and will keep performing for decades to come." Martin Graham, Director of Engineering, Facilities and IT at Piramal Pharma Solutions, praised the team's efforts. "A huge thank you to Kemtile, especially Steve Lyon, Declan Strain and Jay Livingstone together with their install team for their perseverance and commitment throughout this intensive project," he said. Experts from Piramal Engineering and Pharma Site Services Limited were also acknowledged for their support in floor preparation and cleaning activities. Graham added: "Projects like this demonstrate the importance of experience, planning, and collaboration in achieving outstanding results." Kemtile's experience in pharmaceutical environments. Kemtile has more than 40 years' experience supplying hygienic, bespoke flooring systems to cleanroom and pharmaceutical facilities. The company regularly advises manufacturers on complete floor system requirements, offering site surveys, specification, design, groundworks, drainage, site supervision, health and safety compliance and installation.
Piramal Pharma reported early signs of CDMO business recovery with improved RFPs and order inflows during its Q3 2026 earnings call. The company maintained a strong regulatory track record, clearing 30 inspections including 2 US FDA inspections without OAIs. However, the company faced a 3-4% year-over-year revenue decline due to inventory destocking and slower early-stage order inflows. EBITDA margins remained at 11% for the quarter. The consumer healthcare business grew 20% in Q3 and 16% over nine months. Piramal acquired Kenalog from Bristol-Myers Squibb, expecting annualised revenues of $30-40 million. The product aligns with the company's hospital channel strengths and has limited competition due to complex manufacturing requirements. Management expects momentum from improved US biopharma funding to support healthy growth in FY27.
Piramal Pharma acquires Kenalog(R) branded injectable product. Piramal Pharma has acquired Kenalog(R), a branded commercial injectable product, from Bristol-Myers Squibb Company (BMS) for an upfront consideration of US$ 35 million. Contingent consideration up to US$ 65 million is payable on agreed operational and financial milestones. The acquisition is expected to leverage Piramal's distribution network and broaden its product portfolio, especially in the US, Europe & Asia Pacific regions. Kenalog(R) acquisition. Piramal Pharma Limited has entered into definitive agreements to acquire Kenalog(R) and its associated brands from Bristol-Myers Squibb Company (BMS). Deal terms. The acquisition includes an upfront consideration of US$ 35 million. Furthermore, contingent consideration up to US$ 65 million will be payable based on the achievement of certain operational and financial milestones. The transaction is subject to customary closing conditions. About Kenalog(R). Kenalog(R) is a branded commercial injectable product containing Triamcinolone Acetonide, a synthetic corticosteroid used as an adjunctive therapy in acute gouty arthritis, rheumatoid arthritis, and other conditions. It is currently marketed by BMS across 15 countries under trademarks such as Kenalog(R), Kenacort(R), Trigon(R), and Adcortyl(R). Strategic rationale. The acquisition of Kenalog(R) is expected to leverage Piramal's extensive distribution network, which spans over 6,000+ hospitals in more than 100 countries. This move is also anticipated to broaden Piramal's CHG product portfolio, creating new growth opportunities, especially in the US, Europe, and Asia Pacific markets.
Piramal Pharma secures $216 million financing with corporate guarantee.