Director Process Engineering

**Job Title: Director, Process Engineering**
**Location: Switzerland (Remote)**

**Our Mission**:
**Summit Activities**:
We have in-licensed ivonescimab (SMT-112), which is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule taking advantage of cooperative binding between the two. We initiated multiple phase-III clinical studies in the following Lung cancer indications:

- Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (“HARMONi”)
- Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (“HARMONi-3”)
- Ivonescimab is an investigational therapy that is not approved by any regulatory authority. It is currently being investigated in Phase III clinical studies._

**Overview Of Role**

We are seeking an experienced bioprocess engineering professional to join the CMC team and support ongoing process development, technical transfer, BLA/IND/IMPD authoring and agency interaction activities, in preparation for commercialisation (and/or incremental clinical studies). In particular, this role will focus on leading & authoring the CMC chapters of regulatory submitted documents, ensuring all required data integrity and technical compliance standards are met. This role will also contribute strategically and technically to future lifecycle considerations e.g. productivity improvements, scale-up vs. scale-out decisions etc..

**Roles and Responsibilities**
- **BLA/IND/IMPD Authoring**
- Be accountable to successfully deliver CMC chapters to regulatory documents
- Develop and execute processes to ensure data integrity
- Identify and close technical/content/compliance gaps
- Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes (including external vendors when applicable)
- Actively support dialogue/interaction with regulatory agencies
- Support PLI/PAI preparation and delivery
- **Strategic / Technical**
- Develop lifecycle management strategy
- Understand key challenges and opportunities specific to product/process/supply chain
- Prioritise post-approval opportunities and develop business cases for further investment/development
- Support general problem solving and technical/strategic contributions across the CMC department/activities where applicable
- **Regulatory Compliance**
- Stay up to date on relevant regulatory requirements and guidelines related to biologics process development and manufacture
- Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations.
- **Risk Management**
- Identify potential risks and challenges within the development and filing history of products and develop mitigation plans
- Proactively address issues in the moment
- **Vendor Management**
- Oversee relationships with external vendors (where applicable), including CRO’s, consultants and technical services
- **Communication, Collaboration and Leadership**
- Subject matter and personnel leadership accountabilities
- Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CRO’s/CDMO’s.

**Experience, Education and Specialized Knowledge and Skills**
- Bachelor's degree in a relevant scientific discipline; advanced degree preferred
- Minimum 15 years’ experience in bioprocess engineering, supporting the process development, scale-up and manufacture of biologics processes at a pharma, biotech or contract development and manufacturing organization (CDMO)
- Experience with late phase product development, control strategy, validation and authoring/reviewing associated regulatory submissions
- Broad understanding of regulatory and GMP requirements for late phase/commercial biologics products
- Strategic thinker, ability to identify and prioritise action to maximise value and minimise risk over the mid to long term
- Experience in overseeing external vendors
- Comfortable interacting with all levels of the organization, customers, and suppliers
- Able to work with abstract global problems
- Nimble in a highly dynamic and agile organization
- Intuitive with well-honed interpersonal and communication skills
- Effective with global workgroup associates
- A promotor of inclusion and collaboration
- Able to work independently
- Able to handle multiple projects simultaneously while maintaining high-quality results
- Capable of providing and implementing innovative solutions to unique and pressing situations
- Technically proficient in industry standard technology and/or available software, processes, and industr