Principal Drug Product Formulation and Process Specialist – Solid Dosage Forms

3 months ago


København Huse, Denmark Black Swans Exist ApS Full time

Copenhagen
Position Summary : The Drug Product Formulation and Process Specialist will focus on the formulation and process development for solid dosage forms of Live Biotherapeutic Products (LBPs). This role involves close collaboration with Research, Quality, and Regulatory teams to ensure the successful development and production of high-quality solid dosage forms at partner CDMOs.

Key Responsibilities :

Formulation Development :

  • Develop and optimize formulations for solid dosage forms containing LBPs.
  • Supervise pre-formulation studies, including compatibility and stability assessments.
  • Evaluate different excipients and delivery systems to enhance the stability and efficacy of LBPs.

Process Development :

  • Design and develop scalable manufacturing processes for solid dosage forms at partner CDMOs according to phase of development.

Technical Support :

  • Provide technical expertise during technology transfers.
  • Troubleshoot formulation and process-related issues during scale-up.
  • Guide and ensure oversight of outsourced development and manufacturing activities.

Quality and Compliance :

  • Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.
  • Participate in internal and external audits, providing technical documentation and support.

Collaboration and Communication :

  • Work closely with cross-functional teams, including Research, Quality Assurance, and Regulatory Affairs.
  • Communicate effectively with stakeholders to provide updates on formulation and process development activities.
  • Prepare and present technical reports, summaries, and presentations.

Continuous Improvement :

  • Stay current with advancements in formulation technologies and industry trends.
  • Identify opportunities for innovation and improvement in formulation and process development.
  • Participate in professional development activities and training programs.

Qualifications :

Education :

  • Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. Ph.D. preferred.

Experience :

  • Minimum of 8 years of experience in pharmaceutical formulation and process development, with a focus on solid dosage forms.
  • Experience with Live Biotherapeutic Products (LBPs) or other biologics is highly desirable.

Technical Skills :

  • Strong understanding of formulation principles, including excipient selection, drug-excipient interactions, and stability.
  • Proficiency in using pharmaceutical processing equipment and analytical instruments.
  • Experience with process simulation and modeling software is a plus.

Soft Skills :

  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills.
  • Ability to work effectively in a team-oriented, collaborative environment.

Regulatory Knowledge :

  • Familiarity with GMP, FDA, EMA, and other relevant regulatory guidelines.
  • Experience with regulatory submissions and inspections is highly desirable.
#J-18808-Ljbffr

  • København Huse, Denmark Black Swans Exist ApS Full time

    About the RoleAt Black Swans Exist ApS, we are seeking a highly skilled Principal Drug Product Formulation and Process Specialist – Solid Dosage Forms to join our team. This is a unique opportunity to leverage your expertise in formulation and process development to drive the success of our Live Biotherapeutic Products (LBPs).Key ResponsibilitiesAs a...


  • København Huse, Denmark Black Swans Exist ApS Full time

    At Black Swans Exist ApS, we're looking for a highly skilled Senior Formulation and Process Development Expert to join our team. This is an exciting opportunity to work on the development of innovative solid dosage forms containing Live Biotherapeutic Products (LBPs). Job SummaryThis role involves close collaboration with cross-functional teams to ensure the...


  • København Huse, Denmark Black Swans Exist ApS Full time

    About the Role:The Pharmaceutical Formulation Expert will be responsible for developing and optimizing formulations for solid dosage forms containing Live Biotherapeutic Products (LBPs). This role involves close collaboration with cross-functional teams to ensure the successful development and production of high-quality solid dosage forms.Key...


  • København Huse, Denmark Black Swans Exist ApS Full time

    Job Overview:We are seeking an experienced Senior Formulation and Process Development Specialist to join our team at Black Swans Exist ApS in Copenhagen.About the Role:The successful candidate will be responsible for leading the formulation and process development of solid dosage forms for Live Biotherapeutic Products (LBPs). This role involves close...


  • København Huse, Denmark Black Swans Exist ApS Full time

    Job DescriptionCandidates with expertise in solid dosage formulation and process development for Live Biotherapeutic Products are sought after by Black Swans Exist ApS.Key Responsibilities:


  • København, Denmark Danske Bank Full time

    We are looking for a new colleague to join the ‘IT, Security & Data Risk’ team within the second line of defence (‘2LoD’) function at Danske Bank. A key component of this role involves building the procedures and processes for data risk management, including maintaining key risk data that helps 2LoD in monitoring and oversight. Would you like to...


  • København, Denmark H. Lundbeck AS Full time

    Preformulation scientist/specialist, Pharmaceutical Development small molecules Lundbeck’s passion is tied to our goal of restoring healthy mental well-being, so that every person can be their best. We strive to make a real difference for patients by developing innovative treatments that improve the lives of people living with brain diseases. We are...


  • København, Denmark momondo Full time

    At KAYAK Concord, KAYAK, part of Booking Holdings (NASDAQ: BKNG), is the world’s leading travel search engine. With billions of queries across our platforms, we help people find their perfect flight, stay, rental car, cruise, or vacation package. We’re also transforming the in-travel experience with our app and new accommodation software. For more...


  • København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...


  • København, Denmark Genmab AS Full time

    Clinical Drug Supply Manager Apply Locations: Copenhagen, Princeton, NJ Time Type: Full time Posted On: Posted 4 Days Ago Job Requisition ID: R11309 At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and...

  • Principal UI Designer

    3 months ago


    København, Denmark The HubDanske Bank Full time

    Principal UI Designer SYBO is growing. We’re releasing new games, building on the massive success of Subway Surfers as the most downloaded game of all time (4 billion downloads and counting!) and continuing to excite and surprise the most important people in the world: Our players! We're looking for a Principal UI Designer to join the team and guide...


  • København, Denmark momondo Full time

    at KAYAK Cambridge KAYAK, part of Booking Holdings (NASDAQ: BKNG), is the world’s leading travel search engine. With billions of queries across our platforms, we help people find their perfect flight, stay, rental car, cruise, or vacation package. We’re also transforming the in-travel experience with our app and new accommodation software. For more...


  • København, Denmark 3Shape AS Full time

    Position Description: Principal, Capability Region Europe Reports to : Vice President, Head of Region of Region Europe About the job Would you like to be a key part of transforming a rapidly growing MedTech company that has innovation at its core? Are you looking for an opportunity where you can have a significant impact, lead change, and put your stamp on...


  • København, Denmark Københavns Universitet Full time

    PhD Fellowship in Microglassification of Proteins at Department of Pharmacy Faculty of Health and Medical Sciences, University of Copenhagen We are offering a three-year PhD fellowship in microglassification of pharmaceutical proteins commencing 15th of March 2025 or as soon as possible thereafter. Protein drugs have allowed for a safer and more effective...


  • København, Denmark SYBO Games Full time

    Principal UI Designer Apply now We usually respond within two weeks SYBO is growing. We’re releasing new games, building on the massive success of Subway Surfers as the most downloaded game of all time (4 billion downloads and counting!) and continuing to excite and surprise the most important people in the world: Our players! We're looking for a Principal...


  • København, Denmark Danske Bank Full time

    Are you a trusted advisor skilled in providing professional support and advice through effective engagement in identifying, assessing, and communicating financial crime risks? Are you a trusted advisor skilled in providing professional support and advice through effective engagement in identifying, assessing, and communicating financial crime risks? The...


  • København, Denmark 3Shape Full time

    Position Description: Principal, Capability Region Europe Reports to : Vice President, Head of Region of Region Europe About the job Would you like to be a key part of transforming a rapidly growing MedTech company that has innovation at its core? Are you looking for an opportunity where you can have a significant impact, lead change, and put your stamp on...


  • København, Denmark Mars, Incorporated and its Affiliates Full time

    Job Description: This position, reporting into the cluster Cluster Supply Chain Director, is responsible for MW product availability. With the support of regional teams, they will ensure that inventory levels are appropriate to support the business demand plan and inventory cash targets. As such, this role will champion the cluster casefill agenda, driving...


  • København, Denmark H. Lundbeck AS Full time

    Do you have a passion for LC-MS and like to work with “state of the art” technologies? Do you thrive with scientific challenges? Then you may be our new colleague. Your new role – why is this a great opportunity? You will be responsible for planning, conducting, and reporting of in vitro and in vivo ADME studies, including metabolite profiling and...


  • København, Denmark momondo Full time

    at KAYAK Concord KAYAK, part of Booking Holdings (NASDAQ: BKNG), is the world’s leading travel search engine. With billions of queries across our platforms, we help people find their perfect flight, stay, rental car, cruise, or vacation package. We’re also transforming the in-travel experience with our app and new accommodation software. For more...