Project Manager Engineering
Jetzt bewerben

Project Manager Engineering

Vollzeit 54000 - 84000 € / Jahr (geschätzt) Kein Home Office möglich
Jetzt bewerben
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Auf einen Blick

  • Aufgaben: Lead engineering projects in aseptic manufacturing, ensuring compliance and timely delivery.
  • Arbeitgeber: Join a dynamic team focused on GMP-compliant production in the pharmaceutical industry.
  • Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth.
  • Warum dieser Job: Make an impact in aseptic production while working with cutting-edge technology.
  • Gewünschte Qualifikationen: Degree in Engineering and 5+ years managing GMP projects required.
  • Andere Informationen: Fluency in German and English is essential; must be eligible to work in Switzerland.

Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.

Job Description

  • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff.
  • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.
  • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
  • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Qualifications

  • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable.
  • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
  • Ability to run a complex clinical research program independently.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Ability to interact externally and internally to support a global scientific and business strategy.
  • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
  • Must possess excellent oral and written English communication skills.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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Project Manager Engineering Arbeitgeber: headcount AG

At headcount AG, we pride ourselves on being an exceptional employer, particularly for our Project Manager Engineering role in the vibrant pharmaceutical sector of Switzerland. Our collaborative work culture fosters innovation and professional growth, offering employees the chance to lead impactful projects in aseptic manufacturing while ensuring compliance with the highest regulatory standards. With a commitment to employee development and a supportive environment, we provide unique opportunities for career advancement in a dynamic industry.
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Kontaktperson:

headcount AG HR Team

StudySmarter Bewerbungstipps 🤫

So bekommst du den Job: Project Manager Engineering

✨Tip Number 1

Make sure to highlight your experience in managing GMP projects specifically within aseptic manufacturing environments. This is crucial for demonstrating your fit for the role.

✨Tip Number 2

Familiarize yourself with the latest FDA regulations and GMP standards related to aseptic production. Being knowledgeable about these will show your commitment to compliance and readiness for audits.

✨Tip Number 3

Prepare to discuss specific projects you've managed that involved filling line upgrades or new washing lines. Concrete examples will help illustrate your hands-on experience and project management skills.

✨Tip Number 4

Since the role requires communication with suppliers and technical teams, practice articulating your project management approach and how you ensure smooth collaboration across departments.

Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Project Manager Engineering

Project Management
GMP Compliance
Aseptic Manufacturing Knowledge
Regulatory Standards Understanding (FDA)
Budget Management
Supplier Coordination
Technical Communication
Engineering Degree
Problem-Solving Skills
Team Leadership
Production Equipment Expertise
Audit Preparation
Fluent in German and English
Time Management
Risk Management

Tipps für deine Bewerbung 🫡

Understand the Role: Make sure to thoroughly read the job description for the Project Manager Engineering position. Highlight key responsibilities and required qualifications that match your experience.

Tailor Your CV: Customize your CV to emphasize your engineering background and specific experience in aseptic manufacturing environments. Include relevant projects you've managed, focusing on GMP compliance and regulatory standards.

Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for aseptic production and your ability to manage complex projects. Mention your hands-on experience and how it aligns with the company's needs.

Highlight Language Skills: Since the role requires proficiency in both German and English, make sure to clearly state your language skills in your application. If applicable, provide examples of how you've used these languages in a professional context.

Wie du dich auf ein Vorstellungsgespräch bei headcount AG vorbereitest

✨Showcase Your Engineering Expertise

Make sure to highlight your engineering background and any specific projects you've managed in aseptic manufacturing. Be prepared to discuss technical details and how they relate to GMP compliance.

✨Demonstrate Project Management Skills

Prepare examples of how you've successfully managed multiple projects, focusing on budget adherence and timely delivery. Use the STAR method (Situation, Task, Action, Result) to structure your responses.

✨Understand Regulatory Standards

Familiarize yourself with FDA regulations and GMP standards relevant to aseptic production. Be ready to discuss how you ensure compliance in your projects and how you prepare for regulatory audits.

✨Communicate Effectively with Stakeholders

Since you'll be the main point of contact for suppliers and technical teams, practice articulating your communication strategies. Highlight your experience in coordinating efforts and resolving conflicts between different parties.

Project Manager Engineering
headcount AG
Jetzt bewerben
H
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