Cmc Manager

STALICLA is an international and fast-growing biopharmaceutical company on a mission to
build a new therapeutic space for patients with disorders of the developing brain.

As the company is rapidly scaling, STALICLA is looking to recruit a seasoned and agile
PreClinical Safety Expert to support the next stages of the company's development.

CMC Manager
100 % - GENEVA - CH

The role
The CMC Manager will design, execute, and lead early
- to late-stage clinical formulation
development efforts and associated manufacturing in the development of solid/liquid oral
dosage forms for use in clinical studies and potential commercialization.

He/she will serve as a technical expert in the area(s) of expertise throughout the organization
and will coordinate/author/review drug product relevant sections of regulatory documents.
of drug product development and manufacturing plans at external partners.

processes commonly used for solid and liquid oral formulation development.

Your responsibilities

• Serve as the scientific leader in drug product manufacturing & formulation, develop

strategic development plans in alignment with our clinical trial plans and company
goals. Design phase appropriate formulations at different stage of development
(early to late clinical phase) and commercialization.

• Technical expertise in solid/liquid oral dosage form development and scaleup.
• Site selection of CDMO's for drug product development and manufacturing.
• Manages formulation development and clinical manufacturing activities at external

- laboratories and manufacturing facilities.

• Actively communicates, collaborates with, and contributes to other functional areas

- and CDMO to solve problems and achieve goals.

• Oversee tech transfer and future validation of drug product manufacturing

- processes.

• Authors and reviews formulation related sections for regulatory filings,

development reports and other development related documents.

Campus Biotech Innovation Park | Avenue de Sécheron 15 | 1202 Geneva | Switzerland |

Your profile

• Advanced degree in pharmaceutical science, chemical engineering, or related

scientific field.

development in the biopharma industry with at least 5-year track record.

• A proven track record in developing and scaling up oral dosage form from early

clinical development to commercial product.

• Experience and expertise in formulation development of poorly soluble (BCS Class

II/IV) compounds (small molecules).

• Responsible for managing form selection/characterization, preformulation,

formulation development, delivery of clinical supplies, development of efficient and
scalable manufacturing processes.

• Developing CMC strategy for CMC submission documents to support early to late

accordance with the applicable regulatory & scientific standards.

• Understanding regulations, guidelines, procedures, and policies relating to

manufacture and control of medicinal products.

• Ensuring all appropriate CMC regulatory aspects for product release are in place, to

ensure continuity of clinical development.

• Author and review drug product sections in the CMC sections of regulatory

submissions, internal and vendor reports. Scientific writing skills to complete
Regulatory submission documentation.

• Ensuring information submitted for lifecycle maintenance submissions meets

regional requirements, allowing maximum Supply/Production/Quality flexibility with
mínimal unanticipated questions.

• Excellent verbal and written communication skills, ability to effectively work across

levels, functions, and companies.

More about STALICLA
Ready to join a science-driven, international, multidisciplinary, passionate, hard-working, and
meritocratic environment?
STALICLA is suited for individuals with a strong interest in Precision Medicine and
Neurodevelopmental Disorders field, as well as the ability to go above and beyond to make
things happen
As part of its Corporate Social Responsibility policy, STALICLA promotes diversity, inclusion
encouraged to apply.

Campus Biotech Innovation Park | Avenue de Sécheron 15 | 1202 Geneva | Switzerland |

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