ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Under supervision, executes experiments as directed by the supervisor and communicates results as part of multi-disciplinary team(s).

• Applies relevant scientific principles and techniques to research problems.

• Maintains detailed laboratory notebooks.

• Maintains broad knowledge of state-of-the-art principles and techniques and may contribute to the identification of new project areas or technologies.

• Presents findings internally and contributes to the publication of the work of the project team in well-established and peer reviewed journals, subject to internal scientific and legal approval.

• May provide technical and scientific input to the project team.

• Complies with all safety requirements.

• Contributes to general lab operations such as:

  • Equipment maintenance.

  • Identification of capital equipment needs

  • Maintenance of clean and uncluttered work areas

  • Maintain inventory and ordering lab supplies as needed.

Specific duties may also include, but may not be limited to, the following:

• Provides support for high throughput screening including the design of primary assays, the goal of which is the identification of additional hits and new chemical scaffolds.

• Provides support for lead optimization by screening compounds and/or supporting structure activity relationship (SAR) studies involving the characterization of the biological activity of compounds in various assays. Profiles selected compounds in additional cells/assays.

• Provides support for in vivo and in vitro studies as required.

• Assists in the development of biologically relevant alternatives to preclinical animal models.

• Conducts mechanism of drug activity studies utilizing biophysical and biochemical methods.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree in a scientific discipline, preferably Biology, Biochemistry or Chemical Biology with a minimum of 0-1 years’ experience.

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrates technical proficiency, scientific creativity, and the ability to collaborate with others on cross functional teams in a fast-paced, matrixed, environment consisting of internal and external team members.

• Possesses knowledge of scientific principles and concepts and keeps current with relevant scientific literature.

• Proficiency with Microsoft Office- preferably MS Excel and MS PowerPoint.

• Effective verbal and written communication and skills.

• Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Effective planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Enzymatic experience – moderate to high-throughput assays characterization of enzyme activity. Preference for experience with automated fluid handling (e.g. Tecan Fluent).

• Knowledge of and ability to use standard molecular and cell biology techniques.

• Experience with biophysical methods for protein-ligand binding including, but not limited to, SPR, BLI, DSF, and NMR.

Expected Base Salary Range

$58K to $70K

The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC’s medical, dental, vision, and retirement savings plans.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Coordinates and executes in-house bioanalytical method development and validation activities to support bioanalysis for small molecules bioanalysis for clinical / preclinical projects using LC-MS/MS.

• May also monitor and coordinate bioanalytical activities at Contract Research Organizations (CROs) in support of small molecule clinical and/or preclinical development.

• Develops and implements Standard Operating Procedures (SOPs) for GxP bioanalytical workflow(s).

• Collaborates with clinical / preclinical drug development program teams. Defines, coordinates, manages and oversees the bioanalytical project timeline.

• Responsible for the scientific quality of the bioanalytical projects in support of clinical and/or preclinical development.

• Represents the bioanalysis function on the development program teams and presents results, timelines, etc. at project team meetings.

• Performs other tasks and assignments as needed and specified by management.

• Complies with PTC’s laboratory safety guidelines and completes trainings in a timely manner.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Master’s degree in chemistry, biology, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline and a minimum of 8 years of relevant analytical development experience in pharmaceutical, biotechnology, or regulated bioanalytical CRO or other related environment OR a PhD in chemistry, biology, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline and a minimum of 5 years of analytical development experience in a pharmaceutical, biotechnology or bioanalytical CRO or other related environment OR equivalent education and / or experience.

* Special knowledge or skills needed and/or licenses or certificates required.

• Progressively responsible experience in bioanalytical method development, validation and regulated bioanalysis of clinical / preclinical samples (plasma, urine, etc.) using LC/MS/MS techniques.

• Hands on experience with bioanalytical method development and validation in a regulated environment for small molecules.

• Experience managing multiple projects with competing priorities.

• Demonstrated experience writing study reports and regulatory documents.

• Ability to influence without direct authority.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication and skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience writing analytical reports.

• Experience working within or with a Contract Research Organization (CRO).

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

NamedScience’s Top Employer in 2021 and 2022

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

This position is primarily responsible for providing strategic oversight to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (e.g. SDLC, IT Change Control) per associated regulatory and security requirements. Position will oversee and provide QA support for optimizing, troubleshooting, and maintaining key global GMP quality systems including Veeva Quality Docs (electronic document management system), Veeva QMS (electronic Quality Management System), and additional GxP systems for Gene Therapy manufacturing, quality control, warehouse, and clinical programs. The position will serve as the QA lead for Computer Software Validation lifecycle documents, site IT Change Control facilitation and QA review of CSV documents.

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• Manage, maintain, and continuously improve Insmed’s global Electronic Document Management System (EDMS), Quality Management System (QMS), additional Quality owned software platforms (labeling, metrics, etc.) and electronic GxP record archiving.• Serve as QA electronic system validation expert.Provide oversight and QA support on all GxP software used by the Gene Therapy business in accordance with applicable regulations, guidelines, policies and procedures. Types of systems may include: CTMS, LIMS, CMMS, ICN, ERP (inventory management), laboratory equipment software, building management, environmental monitoring, etc.• Train, support and advise end users on EDMS and QMS system requirements and workflows. Develop training modules for EDMS and QMS.• Liaising with corporate QA, eead EDMS and QMS cross functional subject matter expert forum for continuous improvement.• Writes SOPs and other quality system documentation, assists other departments with the generation, review and approval and maintenance of such documents.

• Responsible for the local processes related to QMS, IT Change Control, Computerized System Validation, Data Integrity for electronic systems, and monitoring/auditing of audit trails.• Provide support during regulatory inspections and internal audits.• Experience with Veeva systems is preferred.• Experience implementing, validating, maintaining, and integrating electronic document and Quality Management in an FDA or equivalent regulated settings.• Role-related knowledge: Working knowledge of all GxP regulations and reporting requirements, quality systems, Computer System Validation, and quality management tools.• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development, including delivery of multiple projects of various complexities• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department• Additional duties as may be assigned from time to time

• Education – BS Degree required or preferred• A minimum of 5 years of relevant Quality Assurance experience required. An advanced degree (MS) and a minimum of 3 years relevant experience will also be considered• Experience as QA reviewer of several GMP records and processes: CSV Validation Protocols, Deviations, CAPA, SOPs, etc..• Preferred experience in Data Integrity, 21 CFR Part 11, GAMP, CDLC (Agile or Waterfall)• Must have excellent communication skills (verbal and written).• Demonstrate ability to manage projects and variable workloads.• Highly organized with a strong attention to details, clarity, accuracy, and conciseness. • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies

Up to 10% travel.

We’re committed to investing in every team member’s total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:

• Flexible approach to where and how we work
• Competitive compensation package including bonus.
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan withcompanymatch
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission, and we will keep all submissions on file for six months.