• Login / Signup
    • Instagram
    youtube
    Facebook

    Formulation Scientist

    Syngene
    5+ years
    Not Disclosed
    Bengaluru
    10 Jan. 30, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Formulation Scientist

    Job Location: Syngene, S18, Bengaluru
    Department: Formulation Development Centre (FDC)
    Education Required: Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology)
    Experience Required: Minimum 5 years in industrial research for parenteral drug products

    About Syngene

    Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization (CRDMO), offering comprehensive scientific services from early discovery to commercial supply. Syngene values safety, quality, and integrity in its operations, ensuring that these principles are ingrained in every project undertaken.

    Core Purpose of the Role

    The Formulation Scientist will be responsible for the development and optimization of parenteral drug products, including the full lifecycle from pre-formulation, formulation design, process optimization, and characterization to the technology transfer from R&D to GMP manufacturing sites. The role also involves supporting drug product manufacturing in GMP fill-finish facilities and ensuring right first-time approach to support clinical trials.

    Key Responsibilities

    Product Development

    • Lead the development of parenteral drug products with a focus on formulation design, process optimization, and pre-formulation.
    • Manage technology transfer from R&D to manufacturing sites, ensuring smooth transitions for GMP manufacturing in fill-finish facilities.
    • Ensure successful scale-up of processes using parametric and non-parametric methodologies.
    • Work closely with production and quality teams to facilitate drug product manufacturing.

    Process Development and Optimization

    • Develop and optimize manufacturing processes to ensure the production of high-quality drug products for clinical trials.
    • Apply a right-first-time approach in process optimization to enhance efficiency and product quality.
    • Focus on the optimization of complex injectables, including formulations for pre-filled syringes (PFS), autoinjectors, and other injectable delivery systems.
    • Experience with the design and optimization of lyophilization cycles for large molecules is essential.

    Troubleshooting and Troubleshooting for Batches

    • Drive troubleshooting efforts for clinical batches and registration batches.
    • Resolve scale-up challenges for drug products such as conventional injectables, complex injectables, and combination products.

    Regulatory Compliance and Quality Control

    • Ensure compliance with GMP standards and company’s quality requirements.
    • Write and review lab development and GMP manufacturing documents such as BMR, BPR, and PPQP.
    • Support the closure of QMS activities such as deviations, OOT, OOS, and CAPA.
    • Manage regulatory submissions and responses to regulatory queries for global markets such as US, EU, and ROW.

    External Coordination

    • Coordinate with third-party manufacturing facilities for technology transfer and manufacturing support.
    • Work closely with external partners to ensure smooth transitions of processes and support continuous improvements.

    Client and Stakeholder Interaction

    • Responsible for cross-functional coordination to align project milestones, expectations, and deliverables.
    • Support client visits and audits, ensuring all regulatory and quality aspects are maintained.
    • Communicate effectively with both internal teams and external partners to achieve project goals.

    Skills and Capabilities

    1. Core Competencies:

      • Extensive experience in formulation development for parenteral drug products, including process development, formulation design, and scale-up.
      • Expertise in pre-formulation, comparability studies, and regulatory requirements for injectable systems (vials, PFS, autoinjectors).
      • Hands-on experience in process validation and troubleshooting for complex injectables.

    2. Leadership and Coordination:

      • Proven ability to lead teams and coordinate across functions to manage projects from lab to GMP manufacturing.
      • Expertise in knowledge transfer and training teams effectively.

    3. Quality Approach:

      • In-depth understanding of phase-appropriate GMP and clinical trial supply requirements.
      • Commitment to data integrity and compliance with safety protocols in a GMP environment.

    4. Troubleshooting and Problem Solving:

      • Strong problem-solving skills in handling technical challenges for clinical and registration batches.

    5. External Coordination and Client Interaction:

      • Experience working with third-party manufacturing sites and facilitating successful technology transfers.

    6. Regulatory Knowledge:

      • Hands-on experience with regulatory submissions, and regulatory audits, especially in global markets.
      • Skilled in responding to regulatory queries and drafting regulatory filings.

    Education & Experience Requirements

    • Master of Pharmacy (Pharmaceutics, Industrial Pharmacy, or Process Technology).
    • At least 5 years of industrial experience in formulation development and technology transfer for parenteral drug products, both small and large molecules.

    Syngene Values

    • Excellence
    • Integrity
    • Professionalism

    Equal Opportunity Employer

    Syngene is an Equal Opportunity Employer. The company is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

    Latest Jobs

    Sr. Group Leader - Chemical Research

    Jubilant Pharma
    India

    Research Associate I-Analytical

    Jubilant Pharma
    India

    Staff Pharmacist

    Jubilant Pharma
    California Remote

    Manager, Pharmacy- Detroit, Mi

    Jubilant Pharma
    Detroit Remote

    Research Scientist - Analytical

    Jubilant Pharma
    Greater Noida India

    Microbiologist I / Ii

    Jubilant Pharma
    Remote Wilmington

    Research Associate Ii- Analytical

    Jubilant Pharma
    Greater Noida India

    Regulatory Affairs Project Manager

    Infotree Global Solutions
    Foster City

    Research Associate I-Analytical

    Jubilant Pharma
    Greater Noida India

    Clinical Trial Research Coordinator

    Medasource
    San Francisco

    Pharma Jobs in India

    Andra Pradesh :

    Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Eot Municipality | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji | Verna |

    Gujarat :

    Ahmedabad | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |

    Madhya Pradesh :

    Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |

    Maharashtra :

    Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |

    Odisha :

    Bhubaneswar | Rourkela |

    PAN-India :

    Panjab :

    Pondicherry (Puducherry) :

    Pondicherry (Puducherry) |

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |

    Sikkim :

    Rangpo |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh | Roorkee |

    West Bengal :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |

    Albama :

    Tuscaloosa |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |

    Colorado :

    Boulder | Denver | Westminster |

    Connecticut :

    Bridgeport | Bristol | Enfield | Groton | Hartford | Newtown | South Windsor | Stamford | Storrs | West Hartford |

    D.C :

    Washington |

    Delaware :

    Wilmington |

    Florida :

    Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |

    Georgia :

    Atlanta | Rome |

    Hawaii :

    Hilo | Honolulu |

    Idaho :

    Boise |

    Illinois :

    Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Garden city | Kansas City | Lawrence | McPherson |

    Kentucky :

    Edgewood | Ft MItchell | Louisville | Shelbyville |

    Kington :

    Frank Scottile Blvd |

    LA :

    Baton Rouge | Monroe | New Orleans |

    Louisiana :

    Lake Charles | Shreveport |

    Maine :

    Bangor | Brewer |

    Maryland :

    Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |

    Massachusetts :

    Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |

    Missouri :

    Fulton | Milan | St. Louis |

    Nebraska :

    Hebron | Nebraska City |

    Nevada :

    Las Vegas | Tonopah | Tonopsh | Virginia |

    New Hampshire :

    Lebanon | Manchester |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New Mexico :

    Farmington | Santa Fe | Tucumcari |

    New York :

    Albany | Biddle | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |

    North Carolina :

    Concord | Lumberton | North Carolina |

    North Caroline :

    Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Norwood | Oregoina | oxford | Waynesville |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |

    Pennsylvania :

    Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |

    Portugal :

    Lisbon | Oeiras | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Memphis | Nashville |

    Texas :

    Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |

    United states :

    fairmont | Georgia | OH | United States |

    United States :

    Hawai | kentucky | Sylmar | Woonsocket |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |

    WI :

    Madison | Wausau |

    Wisconsin :

    Portage |

    Wyoming :

    Big Piney | Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Darmstadt | Marburg |

    Hessen :

    Frankfurt | Harveysburg |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    Rhineland Palatinate :

    Ingelheim am Rhein | Mainz |

    Rotherbaum :

    Hamburg |

    Saarland :

    Saarbrucken |

    Saxony Anhalt :

    Halle |

    Schleswig Holstein :

    Kiel |

    Pharma Jobs in Europe

    Belgium :

    Wavre |

    BULGARIA :

    Bulgaria |

    Denmark :

    Copenhagen | Denmark |

    Europe :

    France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |

    Finland :

    Finland |

    Hungary :

    Budapest |

    Istanbul :

    Istanbul | Turkey |

    Norway :

    Norway | NOrway |

    Romania :

    Romania |

    Serbia :

    Belgrade | Serbia |

    Switzerland :

    Basel | Zurich |

    Pharma Jobs in China

    China :

    China | Quarry Bay |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Australia

    Melbourne :

    South Yarra |

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Cork | Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    North Brabant :

    Breda |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & New Zealand & Peru & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    Buenos Aires :

    Buenos Aires |

    Austria :

    Austria |

    Vienna :

    Vienna |

    Antwerp :

    Heist op den Berg |

    Brussels :

    Brussels |

    Flemish Brabant :

    Zaventem |

    Bosnia and Herzegovina :

    Sarajevo |

    Sofia City :

    Sofia |

    Canada :

    Canada |

    Ontario :

    Renfrew | Uxbridge | North York | Mississauga | Richmond Hill |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    Oxfordshire :

    Witney |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    London | Stevenage | Salt Lake City | United Kingdom | Harlow | Leeds | Maidenhead | Stirling | England |

    Estonia :

    Tartu | Estonia |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Athens | Koropi |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Be'Er Sheva | Kfar Saba | Tel Aviv | Netanya | Yavne |

    Italy :

    Italy |

    Lombardy :

    Rho |

    Japan :

    Japan |

    Tokyo :

    Otemachi |

    Kazakhstan :

    Almaty |

    Remote Korea :

    Remote Korea |

    Republic of Korea :

    Seoul |

    Kuala Lumpur :

    Kuala Lumpur |

    Mexico :

    Ciudad de México |

    North Island :

    Auckland |

    Lima Region :

    Lima |

    Cebu Province :

    Cebu City |

    Philippines :

    Manila |

    Mazovia :

    Warsaw |

    Remote :

    Remote - Africa | Remote, USA | Remote - South America (Latin Americal) | Remote - Middle East | Remote | Switzerland | Remote - Europe |

    Bucharest :

    Bucharest |

    Makkah :

    Najran | Rabigh | Jeddah | Riyadh | Khulais | King Abdullah Economic City |

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    Midrand | South Africa |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |