דרושים Biological Researcher Purification Process Development ב-טבע ב-United States, East Bradford Township

Embark on a future with an international pharmaceuticals company, contributing your creative energy to high-impact projects from the moment you arrive through the course of this 12-week experience. You will take part in meaningful work and real-life projects that will help you grow both professionally and personally throughout the program.

• Location: West Chester, PA 19380
• Length: minimum of 12 weeks (TBD during mid-May through mid-August)
• Schedule: You must be available to work a 40-hour work week for 12 weeks
• Pay: TBD

Tasks & responsibilities

• During the 12 week program, you will gain in-depth insight into the Drug Product Development department.
• Learn and apply High Throughput Experimentation (HTE) strategies and equipment
• Explore and develop new formulation technologies
• Gain hands-on experience with dynamic light scattering (DLS), static light scattering (SLS), and full spectrum fluorescence (FSF) to study the colloidal and conformational stability of antibodies
• Learn how to plan and execute scientific experiments: prepare samples, perform testing, record results in electronic notebook, analyze data, prepare final presentation.

Qualifications

• Currently enrolled in an undergraduate program of Chemistry, Biochemistry, or related field
• Prior lab experience is preferred.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

· Perform analytical testing in accordance with regulatory standards and internal policies to support formulation and drug product process development for both liquid and lyophilized dosage forms.

· Generate reliable, high-quality data rooted in sound scientific methodology and record findings in electronic lab notebook.

· Analyze data, interpret results critically, and draw well-supported conclusions.

· Conduct studies to facilitate selection of formulation compositions and container closure systems and execute early-stage process development to support drug product manufacturing.

· Organize and present scientific data effectively in presentations and written reports.

· Employ data analytics to enhance workflow efficiency, data entry accuracy, and data digitalization processes.

Required Qualifications:

· Bachelor’s or Master’s degree in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or a related discipline, relevant experience:

o at least 5 years for Bachelor’s degree

o at least 3 years for Master’s degree

· Demonstrated eagerness to learn and adopt new scientific techniques.

· Strong verbal and written communication skills.

· Proficiency in Microsoft Office Suite.

Preferred Qualifications:

· Background in protein chemistry and protein handling.

· Direct experience with analytical techniques for protein characterization and stability assessment.

· Technical proficiency in experimental execution and troubleshooting.

· Strong organizational skills and attention to detail.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

In your journey with us, your prime responsibilities are:

Operations Management - Responsible for all aspects of day-to-day operations of the team aligned to him / her with respect to (but not limited to) call handling, response and resolution, introduction of new services, workload monitoring and management, performance against service level targets, quality control, call handling, training, education, knowledge management, escalations and continual service improvement

• People and Team Management
• Lead, Coach & mentor a team consisting of Agents & Subject Matter Expert(s)
• Provide monthly feedback on performance to team members
• Provide feedback to the team members with respect to any concerns or improvement opportunities
• Operations Management
• Responsible for maintaining desired level / score(s) & enhancing End User Customer Satisfaction score, Agents’ Quality Tele - Monitoring score(s) and Agents’ Communication skills / score
• Provide hands-on assistance, share information proactively and troubleshoot for your team in case of problems, both, through direct intervention and mentoring and effectively delegate responsibility.
• Ensure quality reporting and work with Operations Manager to build a highly effective measurement and reward systems based on empirical data.
• Controls and Compliance
• Ensure team’s activities conform to controls and the operation is audit ready
• Drive audit readiness of the entire service delivery operation

• Strong understanding of ITIL (IT Infrastructure Library) foundation, Six Sigma & Agile practices
• Six Sigma Green Belt trained (preferably certified)
• Knowledge of Quality Tools, Systems and Processes
• Expert working knowledge on Microsoft Applications - PowerPoint, Excel, MS-Project
• Basic Knowledge on MS-Outlook and MS-Exchange, Networking (VPN/Connectivity Issues), Internet Security, Windows, Mac O/s (Basics), Android, iOS, MS-Teams, Webex, Slack, O365
• Experience with ServiceNow or similar Incident Management Tool
• Experience and Knowledge of Staffing and Scheduling tool(s) like Avaya Workforce Optimization Suite
• Experience with working in a pharma / Biotech / GxP environment is preferred
• Bachelor’s Degree in computer science, Engineering, or related discipline with an IT certificate / diploma
• Quality Certification will be considered as an advantage
• 3+ years' experience as a First Line Manager of ~20 direct reportees, managing a technical service desk team; minimum service desk experience of 8 to 12 years
• Managed teams working in global operations and in 7/24/365 shifts
• 8 to 12 years’ experience in service desk operations
• Extensive experience in service desk operation dealing with complex technology products and services
• Strong communication (verbal and written), presentation and influencing skills
• Problem Determination & analysis skills
• Multi-cultural team management
• Stakeholder management

Dir IT Operations IT Service Operations

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Key Responsibilities:
• Support implementation of new solutions, testing, management, troubleshooting, and administration of new and existing systems within the pharmaceutical laboratory research and development organization.
• Support delivery of IT services and coordination with local, regional and global resources on the status of projects, service and support efforts.
• Collaborate with laboratory business, staff, IT colleagues, vendors, and other stakeholders to support existing processes and technologies. Identify customer requirements; assess impacts to the delivery of applications and other IT functions.
• Involved in implementation of new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards.
• Perform day-to-day system administration, maintenance & operational tasks for the Lab systems and ensures appropriate service levels are developed and monitored.
• Perform PC/System specification configuration according to vendor requirements, works with IT Operations for PC lab build, user group assignment and management, data backup setup and control, test data backup and restore, IQ/OQ test execution and documentation.
• Liaise with IT operational support teams for the peripheral equipment, such as servers, desktops, printers and storage devices.
• Support with tasks and deliverables related to Software Development Life Cycle (SDLC) phases for laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and processes.
• Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems.
• To be the site expert on all laboratory computer systems – LIMS (Labware), CDS (Empower), standard-alone computer driven instrumentation and other applications identified by laboratory management.
• Remotely support other Teva sites across multiple zones as needed.
• Backup & recovery management Commvault.

Qualifications
• Required: Bachelor’s Degree - preferably in Computer Science, Information Systems Management, Computer Engineering, Electrical Engineering, Life Sciences or a related field.

Key Skills and Experience
• Experience working in a highly regulated environment within the pharmaceutical laboratory environment.
• Knowledge and experience of cGMP and its implementation to laboratory instrumentation and laboratory processes.
• Experience in providing face-to-face and remote end user support to laboratory users and applications in a highly regulated environment within the Pharmaceutical Industry.
• Excellent verbal and written English communication skills.
• Knowledge of laboratory technical configurations
• Knowledge of installation of system software and tools
• Knowledge of workflows in the laboratory space.
• Excellent Organizational Skills - ability to manage time and multiple tasks
• Strong problem-solving skills
• May have specialized external certification.
• Has developed proficiency in a range of IT processes or procedures through job-related training and considerable on-the-job experience in a laboratory environment

• Proven experience working as a validation analyst
• Extensive experience in regulated biotech or pharmaceutical companies
• Experience in regulated environment (GLP, GCP or GMP)
• Experience in 21 CFR Part 11, GAMP
• Experience in SDLC (Agile or Waterfall)
• Experience in providing face-to-face and remote business analyst support to laboratory system users in a highly regulated environment within the Pharmaceutical Industry.
• Successful experience working in a team environment and with a multi-disciplinary and global team.

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Support drug substance manufacturing process development activities by executing downstream purification steps at bench-scale and pilot-scale
• Support the development of new purification technologies to improve the efficiency of the Biologics manufacturing process and reduce the cost of goods
• Execute development studies (for example, virus clearance study) at 3rd party labs
• Lead a compliant laboratory operation in accordance with SOPs, internal procedures and policies
• Assist in troubleshooting process and equipment issues and deviations
• Record experiment results in lab notebooks in compliance with Good Documentation Practice, and perform data analysis as needed
• Analyze data and present it at internal team meetings and effectively communicate with supervisor(s)/project leads
• Prepare/review technical documents including development reports, batch records, work instructions, etc
• Interact cross-functionally with upstream process development, analytical, facilities, and other internal and external functions to support successful process development and manufacturing in pilot-scale lab

Additional Responsibilities / Secondary Duties:

• Support cGMP (Current Good Manufacturing Practices) clinical manufacturing campaigns in Biologics Manufacturing Facility, when needed

Qualifications / Education Requirements:

• BS in Chemical engineering or Biotechnology or Chemistry or Biology or related field
• Excellent verbal and written communication skills required.
• Highly motivated individual with the ability to work collaboratively in a team environment.
• Knowledge of protein chemistry and separation science is preferred
• Some previous laboratory coursework or experience is preferred.

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.