The role

As a Pharmaceutical Development Manager (PDM) - Technical Drug Product Steward you will provide expertise, knowledge, and deliveries in the field of pharmaceutical processes and pharmaceutical sciences. You are responsible for all aspects related to process development and technical stewardship from late-stage development to commercial manufacturing to ensure cost effective, robust and safe processes for the manufacture of the drug product. The position will provide oversight of the work performed at CMOs for commercial products. The scope of the role encompasses a wide breadth of lifecycle management of pharmaceutical products, ranging from late-stage development, process validation, commercial manufacturing, technical product stewardship of commercial products as well as contribution towards CMC content for regulatory. It also includes responsibility for the process knowledge of the assigned product(s) throughout the commercial lifecycle, maintaining the oversight of process capability, through data trending and statistical analysis, as well as ensuring seamless flow of knowledge and information across relevant functions within sites.

Tasks and responsibilities

• Working closely with external partners and ensure oversight of manufacturing and processing, including packaging of assigned products
• Ensure robust product stewardship for products manufactured at the CDMOs
• Ensure oversight of technical changes and lead end-to-end change control management related to relevant technical issues, working cross functionally as needed
• Ensure that quality and compliance improvement and savings opportunities are assessed and implemented in alignment with supply chain and Quality Assurance
• Collaborate with internal and external stakeholders to perform risk assessments of manufacturing processes, e.g. scale-up and tech. transfer, and use of Quality by Design (QbD) and statistically principles
• Ensure that scientifically-sound technical data are generated as basis for process robustness assessment that enables key decisions e.g. on process optimization
• Monitor work performed by DP CDMOs, including review of protocols, reports, raw data, methods, masters and executed batch records
• Resolves production issues, deviations and negative trends by interfacing with relevant manufacturing site(s) and key stakeholder including Quality/Regulatory, Engineering, Validation, and Development
• Lead technology transfer of commercial drug product processes to external manufacturing sites
• Work closely with Supply Chain to prepare for new product launches
• Supports preparation of CMC regulatory documentation for regulatory submissions and approvals as needed
• Ensure oversight during inspections and audits, and responds to questions from regulatory bodies
• Participate in the definition and selection of pharmaceutical process equipment, as needed
• Benchmark new technologies and equipment relevant for Calliditas products in both development and commercial phase
• Act to enable knowledge management for processes and products within Calliditas
• Drive implementation of continuous improvements to support robust and reliable, compliant commercial product and manufacturing processes leveraging risk-based processes
• Lead and actively drive diverse process improvements and maintenance projects

Your profile

We believe you have an extensive experience from pharmaceutical development, processing, and manufacturing, preferably from the industry. You have a deep knowledge and hands-on experience of process development, scale-up and validation. You enjoy and have the ability to work in a fast-paced and dynamic environment with changing priorities, and flexibility to support multiple development programs simultaneously. Since you will work closely to Calliditas CMOs you have excellent communication skills and focus on the importance of building good and professional business relationships. You have the ability of solving problems by using innovative thinking and good decision making. To thrive in this position, you enjoy collaboration and teamwork and you are a result-oriented problem-solver with a positive can-do attitude.

Relevant background

• A minimum of 8-10 years’ experience in biotech/pharmaceutical industry within relevant roles
• Master or PhD Degree in chemistry, biochemistry, biochemical engineering, pharmacy or related fields
• Solid experience of manufacturing of clinical material, and/or commercial manufacturing
• Experience of design of experiment and/ or multivariate analysis
• Experience of writing CMC regulatory documents is an advantage
• Proven significant experience of working with external partners, such as development and/or manufacturing organizations
• Understanding of cGMP requirements, QC testing, ICH regulations and regulatory submission contents

Reasons to join the Calliditas Team

• Be a part of a global leader in IgA-Nephropathy and a rapidly growing commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
• Fast paced small company environment
• A unique corporate culture
• Dedicated, experienced and highly skilled colleagues
• Participate on bonus and benefit programs

About Calliditas

Calliditas is a commercial-stage biopharmaceutical company focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. We have our headquarters in Stockholm, Sweden and offices in the USA, Switzerland and France.

Calliditas’ lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO™ and conditional marketing authorization by the European Commission under the trade name KINPEYGO®. Additionally, Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.

Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary Shares are listed on the Nasdaq Global Select Market (ticker: CALT).

Visit www.calliditas.com for further information.

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