Drug Substance Manufacturing Process Lead

vor 1 Monat


Basel, Basel-Stadt, Schweiz Sobi Vollzeit

Job Overview

">

The Senior Process Manager will be responsible for overseeing the manufacturing process of Drug Substances at Sobi. This role involves ensuring compliance, reliability, cost-effectiveness, and sustainability in our production processes.

">

About Us

">

Sobi is a global biopharmaceutical company dedicated to improving the lives of patients with rare diseases. Our team is passionate about innovation and collaboration, working together to develop and manufacture life-changing treatments.

">

Key Responsibilities

">
  • ">
  • As a Subject Matter Expert (SME) for DS Biologics, you will lead cross-functional teams to optimize manufacturing processes and ensure compliance with regulatory requirements.">
  • You will own and execute MSAT projects, such as manufacturing process and cost improvement initiatives, to drive business growth and efficiency.">
  • Participate in internal activities related to manufacturing, including process changes, deviations, risk assessments, and CAPAs.">
  • Issue, review, and approve applicable SOPs and manufacturing instructions to maintain quality standards.">
  • Review and supervise technical studies, qualifications, and validations to ensure accuracy and compliance.">
  • Contribute to the development of new analytical specifications and stability programs and review changes thereof.">
  • Write and review applicable sections of the APR/PQR and registration files, variations, and market expansion.">
  • Support sourcing evaluations of new contract manufacturers and participate in developing supply and quality agreements.">
  • Lead the technical part of product transfers, scale-up activities, validations, and oversees manufacturing at external manufacturers for Sobi projects in clinical and commercial phases.">
  • Stay up-to-date with external biopharmaceutical manufacturing technology advancements and introduce new technologies to improve processes, costs, or yields.">
">

Qualifications and Requirements

">
  • ">
  • A university education in Chemistry, Biology, Biotechnology, Pharmacy, or a similar field.">
  • At least 5 years of experience in development and manufacturing of DS for clinical and commercial use.">
  • Scientific and technical background in CMC development and manufacturing of Drug Substances.">
  • Recognized expert in drug substance manufacturing with demonstrable experience in cross-functional teams.">
  • Regulatory knowledge, communication skills, and fluency in English.">
  • Personal attributes: fulfillment of Sobi CARE values, ability to act independently, good communication skills, strong team player, and personal integrity.">
">

Salary and Benefits

">

This position offers an estimated salary range of $120,000 - $180,000 per year, depending on location and experience. Additionally, Sobi provides comprehensive benefits, including health insurance, retirement plans, and opportunities for professional growth and development.

">

Location

">

This role is based in [insert location], with occasional travel required for meetings and training sessions.

">

What We Offer

">

We offer a dynamic and supportive work environment, where you can grow your career and make a meaningful impact in the lives of patients worldwide.



  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    The ideal candidate will have a strong background in managing complex technical processes, with expertise in drug substance manufacturing for small molecule non-sterile dosage forms. As a key member of our team, you will be responsible for ensuring seamless execution of projects and maintenance of high-quality standards.Responsibilities:Manage subject matter...


  • Basel, Basel-Stadt, Schweiz Sobi Vollzeit

    About the Role:Sobi seeks an experienced Process Manager to oversee the development and manufacturing of Drug Substance small molecule, non-sterile dosage forms for clinical and commercial use. The ideal candidate will have a strong scientific and technical background in CMC development and manufacturing, with expertise in solid and non-sterile dosage forms...

  • Process Chemistry Leader

    vor 2 Monaten


    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Title: Section Head of Process ChemistryAbout the Role:We are seeking a highly experienced Section Head of Process Chemistry to lead our Process Chemistry & Catalysis department within Synthetic Molecules Technical Development. As a key member of our team, you will be responsible for end-to-end process chemistry, from route design to commercial...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. As a key member of our quality assurance department, you will be responsible for ensuring the quality and compliance of our biologic manufacturing processes.**Job Summary**The Senior Quality Assurance Specialist will be responsible for implementing and...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    About the RoleThe Director of Pharmaceutical Development and Manufacturing will lead a team of experts in developing processes for liquid and lyophilized parenteral drug products. The ideal candidate will have extensive experience in pharmaceutical development, particularly with biological drug products.


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Gi Group SA. In this role, you will be responsible for ensuring the quality of our pharmaceutical manufacturing processes and products.About the RoleThis is a full-time position that requires a strong background in quality assurance, with a focus on...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Lead Biologics Process Development TeamAt Lonza, we are expanding our presence in commercial drug product manufacturing and are seeking an experienced Biologics Process Development Lead. This role will be responsible for leading a team of Group Heads and Scientists to drive process development stages for liquid and lyophilized parenteral drug products (DP)...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA, a leading recruitment agency in the pharma industry, is seeking a highly skilled Senior Quality Assurance Specialist to join their team. The ideal candidate will have a strong background in pharmaceutical manufacturing processes, particularly in biologic drug substance production. About the RoleWe are looking for a seasoned professional with...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    We are seeking a highly skilled Quality Assurance Operations Specialist to join our team at Gi Group SA.Job SummaryThe successful candidate will be responsible for implementing and maintaining quality processes, reviewing and releasing materials, and assisting with continuous improvement initiatives related to quality documents and...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Über unsBasel Drug Substance Manufacturing ist ein führendes Unternehmen im Bereich der Arzneimittelproduktion. Mit einer langjährigen Erfahrung und einem starken Team von 720 Mitarbeitern produziert das Unternehmen Large und Small Molecule APIs (Active Pharmaceutical Ingredients) für die kommerzielle und klinische Versorgung.


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About Gi Group SAGi Group SA is a leading international staffing company with a presence in multiple countries. We offer a wide range of services, including temporary and permanent recruitment, as well as HR solutions.Job DescriptionWe are seeking an experienced Senior Biopharmaceutical Quality Assurance Specialist to join our team. As a Senior...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Company OverviewLonza, a leading global player in the life sciences industry, is expanding its capabilities in commercial drug product manufacturing. This growth presents an exciting opportunity for a seasoned leader to join our team and drive process development for late-stage commercial products.Job SummaryWe are seeking an experienced Lead Pharmaceutical...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a Senior Quality Assurance Specialist to join our team in Basel, Switzerland. As a key member of our Quality Operations Unit, you will play a crucial role in ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.Job SummaryThe ideal...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Lonza, a leading global player in the life sciences industry, is expanding its commercial drug product manufacturing capabilities and seeks an experienced Senior Biopharmaceutical Process Development Manager to lead its process development team.About LonzaLonza's products and services have a positive impact on millions of people worldwide. Our commitment to...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Company OverviewRoches' Synthetic Molecules Technical Development department drives innovation and efficiency in the development of synthetic molecules.We are seeking a highly experienced Chief Development Chemist to lead our Process Chemistry Section and contribute to the advancement of our synthetic molecule pipeline.Job SummaryThe Chief Development...

  • Bio Process Engineer

    vor 1 Monat


    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    About the RoleWe are seeking an experienced Bio Process Engineer to join our team at agap2 - HIQ Consulting, specializing in therapeutic protein production.This role offers a unique opportunity to work with top-tier clients in the biopharmaceutical industry, driving process excellence and innovation in a fast-paced environment.Key ResponsibilitiesProcess...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Job DescriptionA challenging opportunity exists for a highly experienced Biologics Drug Product Sales Professional to join our team at Lonza, driving acquisition of new customers and expanding existing ones in the Drug Product Services Business Unit (BU).About UsLonza is a global leader in life sciences operating across three continents. Our greatest...


  • Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    agap2 - HIQ Consulting is a European engineering and operational consulting group with expertise in the pharmaceutical, biotechnology, medical devices, energy, infrastructure, transportation, chemicals, and information technology sectors.We seek a skilled Process Engineer to support our clients in the realization of their projects on-site. As a consultant,...


  • Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    About the RoleWe are seeking an experienced Director to lead our Drug Product Development team in Basel, Switzerland.Job DescriptionThe successful candidate will be responsible for driving process development stages for liquid and lyophilized parenteral drug products (DP) of biologics. This includes ensuring compliance with internal and external...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    We are seeking a Senior Quality Assurance Specialist to join our team at Gi Group SA in Basel, Switzerland. As a key member of our quality operations unit, you will be responsible for ensuring the quality and compliance of all investigational medicinal products manufactured and packed for clinical studies.About the RoleIn this role, you will support and...