Analytical Product Manager Parma

Analytical Product Manager
Parma
Emilia Romagna, Parma

Department**:Corporate Quality Operations**Job Type**:Direct Employee**Team**:Quality**Contract Type**:Permanent**Location**:Parma, IT**_About us_

- Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6, 000 employees (Chiesi Group).

To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:

- **Discover more here

- We are proud to be the largest global pharmaceutical group to be awarded

- **B Corp Certification**, a recognition of

- **high social and environmental standards**.

We are a

- **reliable** company that adopts and promotes a

- **transparent and ethical behavior** at all levels. - We believe that the success of

- **Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors**.

Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors. - We are committed to

- **embrace diversity, inclusion and equal opportunities.

** In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

**_Chiesi Global Rare Diseases_

- Chiesi Global Rare Diseases is a Chiesi Group's business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. - The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders.

The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.

**Purpose

To define the analytical studies with R&D and/or Quality departments to support the commercialization of new products and products in life cycle management after changes.

**Main Responsibilities

- To define the analytical studies for new products and products in life cycle management (Feasibility, Robustness, Formal Studies, Development/Validation and transfer, Extractable and Leachable Stability, Cycling ToR, including the studies to optimize the devices (if any) and to introduce new primary container closures.

- Evaluate and share the results to support the definition of specifications and shelf life.

- To evaluate and share results and criticalities

- To revise the regulatory documentation written for new product registrations (CTD revision)

- To support chemical labs in commercial phase for the new products or products in life cycle management.

**Experience Required

At least 5 years of experience in manufacturing plants and in chemicals drug product development.

**Education

Degree in scientific disciplines (Chemical, Chemical and Pharmaceutical Technologies, Biology)

**Languages

Fluent English

**Skills

**Technical skills**:

- Knowledge of international pharmaceutical legislation (EMA, ICH, FDA, ANVISA, Asian) and the regulatory requirements inherent to development, production, quality control and distribution according to Pharmacopeias (EU and USP) and GMP

- Good Knowledge of the univariate and multivariate statistic (PCA, DOE)

- Good knowledge of the full drug development and manufacturing processes

**Managerial skills/Behaviors**:

Good Communication skills useful to relate with different company departments ranging from R&D to Manufacturing, networking ability and leadership

**Soft Skills

- Communication skills

- Leadership and social influence

- Quality orientation

**_ What we offer_

- You would join a dynamic, fast-growing, challenging and friendly environment.

- In Chiesi we firmly believe that

- **our people are our most valuable asset**, that is why we invest in continuous training, learning and development.

Therefore, we strive to continuously promote and satisfy development needs, paying particular

- **attention to the quality of our working environment and collective well-being.

**We want our people to come to work happy every day, ** and we know how important it is to find the right

- **work-life balance** in order to be able to give our best.

That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.