MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life. At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company's entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly. Our Values serve as the foundation of MannKind's culture. They define who we are, how we act, and guide our interactions every day-both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together. This position can be based out of either Danbury, Ct or Burlington, Ma Job Summary Manages the coordination and preparation of GxP and ISO internal and external audits in accordance with the regulatory standards and using sound judgement in assessing compliance risks. Interactions normally involve matters between functional areas or other company divisions/units and customers. Performs audits, act as lead auditor as well as identifies resources and define plans for other auditors. Essential Job Responsibilities:
Complete auditor qualification using On-the-Job-Trainings where competency in completing auditing steps/ tasks/activities is demonstrated and documented.
Contribute to vendor selection; a process for the identification, evaluation and selection of external providers of goods and services that takes into account quality, business and technology aspects of a vendor's ability to meet defined requirements.
Manages the external audit program for vendors and contract facilities that have direct or in-direct impact on a cGMP/1SO/MDSAP process including drug product, delivery system, and related packaging to ensure compliance to requirements, regulations, and standards.
Maintains the GLP audit program; approving or reapproving Contract Research Organizations (CROs), and/or GLP vendors for compliance, internal company requirements, and other standards.
Maintains the GCP/PV external audit program; audit process of clinical investigators and trial sites, contract research organizations / vendors and related entities providing Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) services to MannKind Corporation.
Maintains the approved vendors list; a list of approved vendors, contract organizations and service providers deemed suitable for use based upon auditing performed.
Manages quality agreements; contract between two parties that identifies specific, agreed upon roles and responsibilities for assurance of a quality commodity or service. Provide a listing of all current agreements and their status as a component of the Annual Product Review submitted the Agency.
Manage supplier change notifications; a notification of a change provided to MannKind by a supplier/vendor that, per the Quality Agreement, does not require MannKind's approval to proceed.
Manage supplier relationship regarding non-conforming materials, deviations and CAPA. Develops and utilizes vendor performance metrics of which are reported on in management review.
Manages the internal audit program that tracks compliance to internal quality systems and company procedures. Audit program applies to all cGMP/1SO/MDSAP regulated operations and areas.
Quality Control (QC) of regulatory submissions; the process for performing review of documents in support of a regulatory submission or clinical quality oversight.
Maintenance of regulations, standards, and guidance's - types of documents of external origin.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary. As a member of the Quality organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented, a communicator, and a team player. Qualifications:
BA/BS degree in a scientific discipline with 10-12 years or MS/MBA degree with 6-8 years related experience or the combination equivalent of training and experience.
Required knowledge of CFR 210 and 211
10-12 years of experience, preferably in pharmaceutical industry or a regulated environment.
Required knowledge of GxP Compliance and ISO standards.
Previous management, supervisory, or project coordination experience is required.
Proficiency in MS Word, Excel and PowerPoint.
Travel 30 to 50 percent
Excellent communication skills both written and verbal.
Strong interpersonal skills. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
$114k-138k yearly est. 60d+ ago
Looking for a job?
Let Zippia find it for you.
Engineer II, Desktop Support Center (Contract to Hire)
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Located at our manufacturing facility in Danbury, CT and reporting to the Sr. Manager, Information Technology, the System Engineer II is responsible for the daily operations of computer hardware, software and cloud applications. Responsible for all levels of troubleshooting technical issues related to hardware and software. Installs software upgrades and configuration changes when required. Runs diagnostics on computer hardware. Responsible for tracking hardware and software asset inventories. Follows through on technical issues until closure. Principal Responsibilities:
Provide lead technical support for computer hardware, operating systems, telephony systems,
and the corporate network.
Provide technical assistance, troubleshooting support, and general systems guidance to office and remote end users.
Perform specialized tasks to maintain computer equipment and their peripherals.
Able to effectively communicate with business owners at all levels.
Install new software and manage software upgrades.
Maintain computer and software inventories.
Manage image preparation and deployment for all hardware types.
Provide system administrator skills to general systems such as McAfee, Malwarebytes, O365, etc.
Perform special projects, as assigned by IT management.
On-call rotation is required.
Education and Experience Qualifications:
BA/BS degree with at least 3 years related experience or the equivalent combination of training and experience.
Formal training in Microsoft support and the Office Suite
Experience with MDM and Apple device management desired
Experience with imaging systems such as SCCM, Ghost, iDrive, etc.
Microsoft certification or similar from other vendors
Experience in Computer System Validation desired
Excellent problem solving skills
Ability to work effectively under pressure
Excellent interpersonal and communication skills
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza (insulin human) inhalation powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit ********************* Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.
$61k-76k yearly est. 57d ago
Associate I/II, Manufacturing Operator (2nd Shift 2:00pm to 10:30pm)
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Job family summary:
Executes quality and manufacturing procedures in order to meet production demands and regulatory requirements. Responsibilities include on-time manufacture of intermediate, semi-finished and finished pharmaceutical products that meet quality standards. Assists with establishing equipment operating specifications, standard operating procedures and improving manufacturing techniques. Assists with equipment maintenance, calibration and resolving technical issues. **2nd Shift 2:00 pm to 10:30 pm with a 10% Shift Differential**
Essential duties and key job responsibilities and essential functions.
Works on assignments that are semi-routine in nature where some judgment is required in resolving problems and making routine recommendations. Exercises some judgment within defined practices and policies in evaluating criteria for obtaining results.
May provide guidance on assignments to other lower-level personnel.
Execute manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment
Performs manufacturing area and equipment setup, cleanup and teardown and sanitization with supervision
Operates manufacturing production equipment, under supervision, as required by Manufacturing Records and Standard Operating Procedures
Performs in-process inspection and testing, under supervision, as required by Manufacturing Records and Standard Operating Procedures
Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms Product Container Labels and Logbooks
Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks
Responsible for observing all Company, Health, Safety and Environmental guidelines
Fully qualified and able to operate approximately 50% of manufacturing equipment.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Section III: Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
High School/GED with minimum of (0-3 years Associate I) or (3 to 5 years Associate II) related experience or the equivalent combination of experience and training.
Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek jumpsuit).
$40k-45k yearly est. 13d ago
Quality Control Internship
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Why You'll Love This Opportunity:
MannKind's Summer Internship Program offers an exciting, hands-on experience in the biotech industry. Interns can work in departments like R&D, Tech Ops, Human Resources, Finance, Legal and Clinical Operations.
As an intern, you will tackle important projects, receive mentorship from industry experts, and build valuable connections. Our program emphasizes innovation, giving you the chance to contribute to groundbreaking projects and cutting-edge solutions. Develop your skills, gain real-world experience, and make a meaningful impact in healthcare.
What You'll Be Doing:
* Learn how the Quality Control laboratory operates and propose suggestions for improvement to increase laboratory compliance and efficiency
* Work with the team to build a more robust HPLC/GC column inventory and storage tracking system
* Maintain and improve chemical and reference standard inventory program
* Help build an instrument usage tracking system to increase laboratory efficiency
* Look into ways AI can help improve laboratory compliance and efficiency
What You Bring to the Table:
* Pursuing a bachelor's degree in a science related discipline
Bonus Points If You Have:
* Preferably within 1-2 years of graduation
* Strong analytical, interpersonal, organizational, and problem-solving skills
* Excellent attention to detail and ability to work independently
* Proficiency in Microsoft Office
* Strong written and verbal communication skills
* Self-motivated and demonstrated learning agility
* You take the initiative to identify opportunities for improvement and act on them without needing constant direction.
* You are open to constructive criticism and use it to improve performance and grow professionally
When and Where You'll Shine:
* Full-time: On site Monday to Friday 9am to 5pm
* Location: Danbury, CT 06810
* Dates of Program: June 15 to August 20, 2026
* A reliable commute or the intention to find temporary housing before starting the internship is required.
At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.
$60k-72k yearly est. 1d ago
Director, Packaging Technology
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease. At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives. Director of Packaging Technology will lead packaging development efforts for new and existing products and support commercial packaging operations, as needed, by managing departmental resources and projects. **This is an onsite position in Danbury, Ct** ESSENTIAL DUTIES AND RESPONSIBILITIES:
Lead and manage the Packaging Technology team to support Development, clinical and commercial packaging requirements.
Direct and initiate the timely development of high quality, innovative packages worldwide based on Commercial, Regulatory and Product Development objectives.
Develop the package utilizing the technical support groups (Manufacturing, Engineering) to achieve the intended design, quality, cost objectives, functionality and manufacturability. Assess and provide project justification including feasibility, function, manufacturability, component cost, tooling estimates, timetable, risks, and global consistency for each of the designs.
Support and summarize with critical issues and action-plan the design review process meeting with Marketing, Manufacturing, Engineering, Regulatory and Quality Assurance.
Direct technology transfers for packaging processes to internal site/s and Contract Manufacturing Organizations (CMOs).
Oversee and contribute to the preparation of all regulatory submission documentation to support registration filings.
Manage the creation of printed component labeling artwork with input from Regulatory, Commercial, Manufacturing, Legal, etc.
Selection of packaging material supply with Purchasing, insuring the proper quality, economic and business benefits.
Oversee the creation of, and review and sign all material specifications.
Assure that packaging meets the needs of the brand, corporation, Regulatory and Environmental Legislation, and consumer safety.
Actively participate on multifunctional teams providing leadership and creative solutions while exhibiting an enthusiastic flexible and positive attitude.
Support the design and selection of packaging equipment.
MINIMUM QUALIFICATIONS:
B.S. in Package Engineering, or comparable Engineering discipline
15 years package development experience in the pharmaceutical or medical device industry, preferably with inhalation products. Experience includes work with international projects
8 years management experience
Consistent, proven leadership experience
Demonstrated success in product development and market launches
Ability to work in a fast paced environment with shifting priorities.
Critical thinking skills with the ability to make solid decisions in the face of limited information
Excellent interpersonal skills to allow effective participation in project teams, and the ability to work collaboratively across a number of disciplines and functional groups
Detail oriented with the flexibility to evaluate the need for detail against the overall project needs
Excellent oral and written communication skills
Driven and self-motivated
$122k-163k yearly est. 7d ago
Packaging Engineer I, Pharmaceutical
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Responsible for Package Technology projects necessary to assist with the design, develop and transfer cost effective and sound packaging for pharmaceutical products. Help to determine packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, handling and tampering. Essential Responsibilities / Duties Works on problems in which analysis of situation or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Interacts in a team environment as part of the development, transfer and launch project structures, as well as required to work independently on the technical and regulatory tasks necessary to support corporate and team goals. Design drug product packaging in support of the drug development process by identifying:
Critical drug product attributes as defined by Development teams
Commercialization requirements set by Marketing
Regulatory needs supporting NDA submission, review and approval
Production efficiency and standards as necessary
Assist with developing packaging technologies using engineering principles and scientific analysis to collect and synthesize data relating to package and drug product performance.
Assist with implementing package design solutions in a commercial environment, by leading & coordinating project activities, including equipment selection, procurement and qualification and logistics associated with contract packaging sites.
Help support clinical supply activities by designing appropriate drug product packaging.
assist with scale up packaging technologies to production by compiling and executing the necessary technical and financial plans.
Help write, create and establish regulatory and purchasing specifications for packaging requirements (components, in process controls) based upon development and transfer activities.
Coordinate and participate in the launch activities related to packaging which are required to support new product introductions.
Participate in project teams as required utilizing good communication, analytical, organizational and leadership skills.
Assist with generating written development and investigational reports in support of package components, materials, equipment and processes. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
BS Degree in Package Engineering or related field, with a minimum 5-8 years' experience in package engineering in pharmaceuticals or related field, or MS degree with 3-6 years' experience in package engineering in pharmaceutical or related field.
Working knowledge of materials test methodology, laboratory procedures and packaging equipment.
Strong organizational skills and ability to manage multiple responsibilities.
Knowledge of cGMP's and various regulatory aspects affecting pharmaceutical packaging development and operations.
$79k-102k yearly est. 60d+ ago
Manager, Logistics and Warehouse Operations
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
With the acquisition of ScPharmaceuticals, MannKind has expanded into the cardiometabolic space, adding FUROSCIX to its portfolio and reinforcing its commitment to innovative, patient-centric solutions across chronic and complex conditions. Job Summary: The Warehouse Operations Manager is responsible for the Warehousing, Shipping, and Receiving functions and ensuring compliance with internal procedures and external standards are The position oversees all aspects of the company's pharmaceutical warehouse activities, including the storage and distribution of raw materials, intermediates, and finished products. The primary objective is to ensure efficient operations while maintaining strict adherence to all applicable regulatory standards, such as Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and FDA regulations. Essential Duties:
Team Leadership & Management:
Direct the warehousing and receiving staff and/or functions.
Responsible for providing regular performance feedback, development, and coaching for direct reports.
Responsible for obtaining and maintaining a Designated Representative certification for MannKind's State Licensing program for the sale and distribution of pharmaceutical and medical devices.
Shipping & Receiving Operations:
Supervise receipt and shipment from suppliers.
Assure systems are in place to reconcile orders.
Prepare records of receipt for incoming materials and equipment in accordance with SOX requirements.
Responsible for the accuracy of all shipping documents (bills of lading, computer entry and tracking, inventory records, receiving reports, stock location tags, returned goods records, etc.).
Collect and disseminate information for claims on in-transit damaged materials.
Inventory & Storage Management:
Responsible for maintaining MannKind's Danbury Site as a Foreign Trade Zone (FTZ) according to USCBP rules and regulations
Supervise internal transfer of materials and ensure appropriate procedures are in place to meet internal quality and financial compliance.
Supervise warehousing of materials and assure all materials are stored in compliance with quality, environmental and safety procedures.
Develop ways to increase capacity within space constraints.
Quality & Compliance:
Ensure compliance with cGMPs, SOX, FDA, FAA, ISO and OSHA regulations.
Write and/or review SOPs, as needed.
Represent Warehouse Operations in internal and external audits.
General Operations & Safety:
Responsible for observing all Company, Health, Safety and Environmental guidelines.
All other functions within Warehouse Operations including special projects requested by Management.
Qualifications:
BA/BS in a technical discipline with 7-10 years of experience in a regulated pharmaceutical environment or MS/MBA with 5-7 years related experience or an equivalent combination of training and related experience
7 years management experience, preferably in a cGMP warehouse environment
Strong leadership, management, problem-solving, and organizational skills. Excellent attention to detail and communication skills.
Deep expertise in cGMP, GDP, FDA, DSCSA, SOX, OSHA, and other relevant regulatory requirements for material handling and logistics. Experience presenting during audits/inspections is required.
Experience with inventory management and control
Knowledge of IATA, DOT shipping and HAZWOPER procedures
The ability to effectively use PC software applications, such as MS Word, Excel, PowerPoint, Project, MRP applications etc.
Ability to work independently with minimal supervision
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
$39k-45k yearly est. 49d ago
Senior Thought Leader Liaison, Immunology
Genentech 4.5
Connecticut job
Why Genentech
We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society.
About this Marketing Role:
The Senior TLL role at Genentech is a crucial link between the company and National & Regional Therapeutic Area Experts (TAEs) across Immunology. The Senior TLL will garner insights to refine strategy and execution, develop advocacy to shape market beliefs and behaviors, and enhance connections with National and Regional Therapeutic Area Experts (TAEs) within their geography. The Senior TLL will demonstrate capabilities to translate TAE insights into actionable feedback to shape brand and squad strategies and execution. The Senior TLL supports pull through of Squad priorities and brand strategies to local/regional Customer Engagement (CE) opportunities and partners with CE leadership to shape advocacy in local markets.
Key Roles & Responsibilities:
Establish and foster effective partnerships with National and Regional Thought Leaders
Develop advocacy among National and Regional TAEs to further advance squad and brand priorities
Ability to understand, integrate, and synthesize insights across customers, competitors, therapeutic or business areas and markets to shape strategic planning and customer impact
Coordinate and communicate with internal stakeholders (e.g., Squad leadership, customer engagement roles, marketing, USMA network, compliance, and legal) to ensure cohesive and compliant understanding of Therapeutic Area (TA) strategy, priorities, and needs.
Acts with urgency in ensuring our TAEs are educated on the most up-to-date data and messages for our brands and markets and compliantly correcting any misperceptions
Partner with medical to lead overarching TAE strategy for brands, indications & launches; each function independently determines final strategies, tactics & activities
Compliantly manage Fee-for-service activities that include TAEs (selection / pull through as appropriate)
Effectively influences customer perception and advocacy for current and future products, and leverages relationships with these customers appropriately to meet the needs of all GNE partners (brand marketing, CE, medical, global)
Actively participates on core Marketing and TLL sub-teams (e.g., ad board planning/execution, insights, congresses)
Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities
Accountable for being fully knowledgeable of and compliant with all relevant company policies and procedures, and applicable laws and regulations that govern conduct of GNE activities
Business travel, by air or car, is regularly required
This is a field based position located in the territory of CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT. Relocation benefits are not provided for this role.
Demonstrates Proficiency within the following Key Competencies
Sr. Thought Leader Liaisons are expected to consistently perform at a proficient level (proficient is defined as leveraging competencies across the business in a consistent, integrated way)
Customer Understanding - I'm always learning about my customers, what they need, and the world they live in.
Competitive Value Creation - I determine the relevant, competitive, and profitable value story we offer to customers.
Strategy Development - I make smart choices about what efforts will help achieve customers' goals and our goals.
Execution Readiness - I rally the organization to plan, coordinate, and pull through the strategy together.
Delivery & Optimization Across Channels - I make sure our story is reaching customers in a seamless, memorable experience.
Measurement & Iteration - I evaluate everything we do, and adjust, stop, or start for continuous improvement.
Knowledge/Skills:
Deep knowledge of National and Regional TAEs with a preference for strong relationships among TAEs within geography
Deep knowledge of each customer type (e.g. HCPs, patients, payers, IDNs, distributors, pathways) and how TAEs may engage with various customer types
Ability to educate and challenge TAEs
Understanding of partners, their roles and leveraging their expertise to effectively partner, engage, and mobilize key internal stakeholders.
Ability to articulate business problems and identify solutions
Direct experiences with interpreting and applying market, customer, product or competitor data and utilizing data effectively for making decisions
Ability to utilize computer programs to build and share presentations, utilize spreadsheets to decipher important insights, and host virtual meetings with internal stakeholders/customers
Ability to successfully manage cross-functional projects in collaboration with other internal stakeholders and vendors
Ability to think with an enterprise mindset
Ability to influence and inspire individuals and teams across the CMG network, from front-line employees to the executive level
Ability to flex and thrive in an ambiguous environment undergoing transformational change
Strong financial acumen and analytical skills to effectively interpret and utilize quantitative and qualitative data
Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
Who You Are:
Minimum Candidate Qualifications & Experience:
Bachelors' Degree
A minimum of 5 years cross-functional industry experience in life sciences (pharma or biotechnology) or related industry (e.g., payers, health systems), is required
Additional Desired Candidate Qualifications & Experience:
Graduate Level degree
Immunology experience, specifically across Rheumatology & Nephrology
Thought Leader Liaison experience
Previous experience in Commercial functions
Experience in shaping or influencing marketing strategies, plans, and tactics
Proven and thorough knowledge of Commercial issues associated with highly competitive therapeutic area
Proven track record of consistent achievement or overachievement in assigned responsibilities, goals, objectives and any other relevant metrics
Previous experience building, implementing and seamlessly executing action plans, programs and related activities
Location:
This is a field based position located in the territory of CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT.
Relocation benefits are not provided for this role.
Individual must reside within the territory boundaries given extensive travel requirements of the TLL role
Approximate travel: 60%+ overnight travel (including weekends)
This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.
The expected salary range for this position based on the primary location of NY is $159,300 - $295,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Roche Operating Principles
Put Patients First: I always act as if patients I know are in the room and do what's best for them
Follow the science: I seek answers through experiments, data and debate, and act on facts
Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part
Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others
Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures
Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less
Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty
Think long term: I choose actions today that benefit future generations
#LI-JW2
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
$159.3k-295.8k yearly Auto-Apply 16d ago
Engineer II, Validation
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. Summary The Engineer II, Validation understands validation methodology and can apply it to process, packaging, equipment, and cleaning activities. Generates and executes validation protocols with limited supervision. Adheres to validation schedules. Essential Duties and Job Responsibilities
Implements the Process and Cleaning Validation Program protocols and helps maintain the Equipment Validation Lifecycle process.
Monitors reoccurring validation activities to meet schedule and production timelines.
Writes validation protocols and reports with limited supervision.
Writes Equipment standard operating procedures.
Generates URSs, IOQ, PQ, and PPQ documentation with limited supervision.
Participates in risk assessments for product and process definition.
Adheres to and maintains compliance with corporate polices and values throughout Manufacturing Technical Services.
Adheres to and promotes MannKind Vision and Values, Code of Business Conduct and Ethics .
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments. Qualification and Essential Duties
BA/BS in a technical discipline with 2-4 of experience or MS with 1-3 years related experience or an equivalent combination of training and related experience
Knowledge in risk assessment tools
Knowledge of bulk powder manufacturing and filling, packaging technology, and kitting desirable.
Excellent written and verbal skills with the ability to communicate clearly, concisely, and effectively.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485, European requirements, etc.)
$79k-99k yearly est. 60d+ ago
Specialist I, QA Floor (2nd Shift, M-F) Contract to Hire
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Job Summary:
Ensures processes and products conform to established company and regulatory standards. Reviews, analyzes and reports on quality discrepancies related to manufacturing and testing of product and company systems. Investigates problems and recommends disposition and corrective actions for recurring discrepancies. Uses predetermined methods, operations and procedures to inspect and test raw materials, work-in-process, finished product as applicable. This is a 2nd Shift position. Hours are from 2:00pm to 10:30pm.
Essential Duties:
* Identify, communicate and escalate basic technical issues.
* Identify options for resolutions and lead implementation of corrective actions.
* Prioritize own work and works independently on day-to-day activities, additional supervision/guidance for new assignments.
* Point of contact on the manufacturing floor as needed
* Review executed batch records - real time remediation to prevent deviation (e.g., GDP, settings, alarm response)
* Perform QA activities in the batch record.
* Verify entries occur real time in batch records
* Perform QC/Retain sampling for each batch
* General observations regarding procedural compliance of staff.
* Observe the gowning and flow of materials and people.
* Review all operations for the batch were performed accordance with BR.
* Identify, communicate and escalate compliance issues, identify options for resolutions
* Perform data entry and execute records in electronic systems.
* Responsible for observing all Company, Health, Safety and Environmental guidelines
* Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Minimum qualifications:
* HS/GED with 2-3 years' experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 1-2 years related experience preferably in the pharmaceutical industry or the combination equivalent of training and experience.
* Knowledge of GxP Compliance and ISO standards.
* Ability to work autonomously to problem-solve, demonstrating excellent analytical skills
* Excellent written and verbal communication skills.
* Physical Required
* Must be willing and able to receive medical clearance to wear a respirator (i.e. Powered Air Purifying Respirator) for entire working shift.
* Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e. Tyvek jumpsuit).
$90k-116k yearly est. 13d ago
Supervisor, Quality Control
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With the recent acquisition of ScPharmaceuticals, MannKind has expanded into the cardiometabolic space, adding FUROSCIX to its portfolio and reinforcing its commitment to innovative, patient-centric solutions across chronic and complex conditions.
Job Summary
Develops, implements and maintains the activities of quality control systems. Oversees methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products. Contributes information to help develop budgets. Makes recommendations for corrective action necessary to assure conformity with quality specifications. Assures finished products conform to government and company standards and satisfies GMP regulations.
Essential duties and responsibilities
Provide general or direct supervision to exempt employees and/or skilled nonexempt employees
Act as advisor to unit or sub-units, becomes actively involved as required to meet schedules or resolve problems
Provides supervision on the floor enforcing compliance data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, logbook, chromatograms, sequences, etc.
In-depth experience with OOS/OOT investigations, root cause analysis, and CAPA implementation.
Comprehensive understanding of 21 CFR Parts 210 & 211 and their application in a GMP-regulated environment.
Advanced troubleshooting skills for HPLC, GC, PSD, and other chemical analysis techniques.
Knowledge of USP General Chapters, system suitability, and instrument qualification.
Experience with method validations, verifications, and transfers in compliance with USP and ICH guidelines.
Ability to critically review analytical data for anomalies and trends, ensuring compliance with SOPs, specifications, and cGMP requirements.
Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities
Exercise judgment within defined procedures and policies to determine appropriate action. Critically review data for anomalies or trends and approve data
Lead and approve investigations of suspect or out of specification results. Ensures implementation of CAPA.
May perform bench analysis, as needed
Frequently interacts with subordinates, outside customers, and functional peer groups at various management levels
Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc. Contributes to cross functional projects with significant impact to company
Responsible for observing all Company, Health, Safety and Environmental guidelines
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
Minimum qualifications
BS degree in a scientific discipline with 5+ years' experience or MS with 3+ years of experience or a combination of experience and training
Experience with HPLC is required
Empower software experience is required
Proficiency in MS Word, Excel, and PowerPoint
Strong interpersonal and organizational skills
Supervisory experience
$71k-85k yearly est. 60d+ ago
Facilities Engineering Internship
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Why You'll Love This Opportunity:
MannKind's Summer Internship Program offers an exciting, hands-on experience in the biotech industry. Interns can work in departments like R&D, Tech Ops, Human Resources, Finance, Legal and Clinical Operations.
As an intern, you will tackle important projects, receive mentorship from industry experts, and build valuable connections. Our program emphasizes innovation, giving you the chance to contribute to groundbreaking projects and cutting-edge solutions. Develop your skills, gain real-world experience, and make a meaningful impact in healthcare.
What You'll Be Doing:
* Participate in facilities projects, including ongoing construction projects
* Support repair projects and initiatives on campus on critical systems
* Review engineering standards for room finishes and hardware
* Review and revise site engineering specs with assistance from engineering
* Organize and evaluate documents in new Facilities Document Archive Room
* Make minor modifications to drawings in AutoCAD as needed
What You Bring to the Table:
* Completing a major/schooling in an engineering discipline (Chemical, Mechanical, Electrical) or technical discipline (Engineering Technology, Industrial Maintenance Technology, etc)
* 3.0 GPA or equivalent.
* Able to work 40 hours per week for the full 8-12 weeks (no vacation weeks)
* AutoCAD 2D Software competency
* Competency with PDF reading/editing software
* Familiarity with Process and Instrumentation Drawings (P&IDs)
* Fluency with Microsoft Office 365 and Outlook
* General tech-savvy ability to leverage modern technology.
* Superior time management and organizational skills
* An intrinsic motivation to continually improve and optimize processes.
Bonus Points If You Have:
* Experience within life sciences, pharmaceuticals, or biotech industries
* Experience with project management software such as Asana, Microsoft Project/Planner
* Preferably within 1-2 years of graduation
* Strong analytical, interpersonal, organizational, and problem-solving skills
* Excellent attention to detail and ability to work independently
* Proficiency in Microsoft Excel and other financial software programs (Power Bl and TM1 bonus)
* Strong written and verbal communication skills
* Self-motivated and demonstrated learning agility
* You take the initiative to identify opportunities for improvement and act on them without needing constant direction.
* You are open to constructive criticism and use it to improve performance and grow professionally
When and Where You'll Shine:
* Full-time: Schedule M-F 8AM-430PM
* Location: Danbury CT
* Dates of Program: June 15 to August 20, 2026
* A reliable commute or the intention to find temporary housing before starting the internship is required.
At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.
$44k-59k yearly est. 6d ago
Packaging Technology Internship
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Why You'll Love This Opportunity:
MannKind's Summer Internship Program offers an exciting, hands-on experience in the biotech industry. Interns can work in departments like R&D, Tech Ops, Human Resources, Finance, Legal and Clinical Operations.
As an intern, you will tackle important projects, receive mentorship from industry experts, and build valuable connections. Our program emphasizes innovation, giving you the chance to contribute to groundbreaking projects and cutting-edge solutions. Develop your skills, gain real-world experience, and make a meaningful impact in healthcare.
What You'll Be Doing:
* As a part of the Packaging Technology team, you will learn fundamentals of pharmaceutical packaging including package design, material testing, and labeling development.
* You will report to a Package Engineer and support their project work; this may involve working as a part of drug development team, problem solving a production line issue, or working with Supply Chain to set up new materials for use in Production.
* You will be required to operate independently and manage your time in order to complete a variety of tasks according to pre-defined due dates.
* This position is required to be on site 40 hours per week.
What You Bring to the Table:
* Completing a major in a business-related discipline.
* 3.0 GPA or equivalent preferred
* Must be able to work 40 hours per week for the full 12 weeks (no vacation weeks) minus shut down the week of Fourth of July
* You enjoy collaborating with others and can resolve conflict with tact and professionalism.
* You are fluent with Microsoft Office 365 and Teams.
* You have a general tech-savvy ability to leverage modern technology.
Bonus Points If You Have:
* Preferably within 1-2 years of graduation
* Prior experience within life sciences, pharmaceuticals, or biotech industries
* Project management certification
* Experience with project management software such as Asana, Microsoft Project/Planner
* You possess superior time management and organizational skills.
* You have an intrinsic motivation to continually improve and optimize processes.
* You take the initiative to identify opportunities for improvement and act on them without needing constant direction.
* You are open to constructive criticism and use it to improve performance and grow professionally
When and Where You'll Shine:
* Full-time: Schedule (Onsite Mon-Thu, Remote Fri)
* Location: Danbury
* Dates of Program: June 15 to August 20, 2026
* A reliable commute or the intention to find temporary housing before starting the internship is required.
At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.
$39k-48k yearly est. 7d ago
Engineer I, Process Development
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. We are seeking a highly motivated engineer to join the Process Development group supporting the small-molecule process development of respiratory drug products in the MannKind pipeline. The candidate is expected to support the development of our novel pulmonary formulations through contribution to the CMC project teams and must be able to meet development goals within ambitious timelines. The work environment is highly collaborative, requires excellent communication skills and the ability to be part of a cross-functional product development team. Responsibilities:
Development and optimization of manufacturing processes from bench scale to commercial scale.
Design, conduct, evaluate and interpret scientific studies to drive the development and understanding of our inhaled dosage forms.
Support technology transfers to commercial manufacturing.
Support equipment and process validation.
Manufacture of development batches and GMP clinical lots.
Assist in the management and troubleshooting of manufacturing operations, including product development studies and reviewing batch records.
Author protocols, pharmaceutical development reports, SOPs, and other scientific/technical documents, which may support regulatory filings.
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Responsible for observing all Company, Quality Assurance guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Skills and Attributes:
Exceptional scientific, technical, and problem-solving skills with the ability to design experiments and interpret data independently.
Demonstrate an understanding of process development, analytical chemistry and drug product characterization.
Knowledge of statistical analysis tools, in particular experimental design, and interpretation of complex data sets.
Excellent technical laboratory skills.
Excellent oral and written communication skills.
Ability to think strategically and creatively.
Experience with inhaled pharmaceutical products is a plus.
Competency in the principles and practice of cGMPs for drug product manufacturing is a plus.
Knowledge of materials science is a plus.
Experience with process scale-up or working across process scales is a plus.
Experience with manufacturing clinical and commercial drug products is a plus.
Familiarity/experience with particle engineering and/or wet-stirred media milling and spray drying is a plus.
The role may require lifting 50 lbs and standing for long periods of time.
Education and Experience:
BS/BA in Chemical Engineering, Materials Science/Engineering, Chemistry, Pharmaceutical Sciences or a related field. 2+ years of relevant experience is preferred.
Ability to work in a laboratory and manufacturing facility that handles active pharmaceutical ingredients.
Must be authorized to work in the United States for any employer without the need for sponsorship.
$75k-98k yearly est. 60d+ ago
Quality Control Microbiology Internship
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Why You'll Love This Opportunity:
MannKind's Summer Internship Program offers an exciting, hands-on experience in the biotech industry. Interns can work in departments like R&D, Tech Ops, Human Resources, Finance, Legal and Clinical Operations.
As an intern, you will tackle important projects, receive mentorship from industry experts, and build valuable connections. Our program emphasizes innovation, giving you the chance to contribute to groundbreaking projects and cutting-edge solutions. Develop your skills, gain real-world experience, and make a meaningful impact in healthcare.
What You'll Be Doing:
* Preparation of Microbiological media and buffer
* Perform cleaning/washing of glassware, bench surfaces and instruments
* Maintain cultures of live microorganisms
* Perform sterilization of consumables using laboratory autoclaves
* Assist with setup during QC testing of Drug Products or Raw Materials
* Conduct routine cleaning/washing of glassware, bench surfaces and instruments
What You Bring to the Table:
* Pursuing a bachelor's degree in Biology
Bonus Points If You Have:
* Preferably within 1-2 years of graduation
* Strong analytical, interpersonal, organizational, and problem-solving skills
* Excellent attention to detail and ability to work independently
* Proficiency in Microsoft Excel and other financial software programs (Power Bl and TM1 bonus)
* Strong written and verbal communication skills
* Self-motivated and demonstrated learning agility
* You take the initiative to identify opportunities for improvement and act on them without needing constant direction.
* You are open to constructive criticism and use it to improve performance and grow professionally
When and Where You'll Shine:
* Full-time: Schedule (Onsite Mon - Fri)
* Location: Danbury, CT
* Dates of Program: June 15 to August 20, 2026
* A reliable commute or the intention to find temporary housing before starting the internship is required.
At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.
$60k-72k yearly est. 5d ago
Director, Packaging Technology
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
POSITION SUMMARY:
Director of Packaging Technology will lead packaging development efforts for new and existing products and support commercial packaging operations, as needed, by managing departmental resources and projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Lead and manage the Packaging Technology team to support Development, clinical and commercial packaging requirements.
* Direct and initiate the timely development of high quality, innovative packages worldwide based on Commercial, Regulatory and Product Development objectives.
* Develop the package utilizing the technical support groups (Manufacturing, Engineering) to achieve the intended design, quality, cost objectives, functionality and manufacturability. Assess and provide project justification including feasibility, function, manufacturability, component cost, tooling estimates, timetable, risks, and global consistency for each of the designs.
* Support and summarize with critical issues and action-plan the design review process meeting with Marketing, Manufacturing, Engineering, Regulatory and Quality Assurance.
* Direct technology transfers for packaging processes to internal site/s and Contract Manufacturing Organizations (CMOs).
* Oversee and contribute to the preparation of all regulatory submission documentation to support registration filings.
* Manage the creation of printed component labeling artwork with input from Regulatory, Commercial, Manufacturing, Legal, etc.
* Selection of packaging material supply with Purchasing, insuring the proper quality, economic and business benefits.
* Oversee the creation of, and review and sign all material specifications.
* Assure that packaging meets the needs of the brand, corporation, Regulatory and Environmental Legislation, and consumer safety.
* Actively participate on multifunctional teams providing leadership and creative solutions while exhibiting an enthusiastic flexible and positive attitude.
* Support the design and selection of packaging equipment.
MINIMUM QUALIFICATIONS:
* B.S. in Package Engineering, or comparable Engineering discipline
* 15 years package development experience in the pharmaceutical or medical device industry, preferably with inhalation products. Experience includes work with international projects
* 8 years management experience
* Consistent, proven leadership experience
* Demonstrated success in product development and market launches
* Ability to work in a fast paced environment with shifting priorities.
* Critical thinking skills with the ability to make solid decisions in the face of limited information
* Excellent interpersonal skills to allow effective participation in project teams, and the ability to work collaboratively across a number of disciplines and functional groups
* Detail oriented with the flexibility to evaluate the need for detail against the overall project needs
* Excellent oral and written communication skills
* Driven and self-motivated
$122k-163k yearly est. 8d ago
Senior Thought Leader Liaison, Immunology
Genentech 4.5
Bridgeport, CT job
Senior Thought Leader Liaison, Immunology Why Genentech We're passionate about delivering on Our Promise to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society.
About this Marketing Role:
The Senior TLL role at Genentech is a crucial link between the company and National & Regional Therapeutic Area Experts (TAEs) across Immunology. The Senior TLL will garner insights to refine strategy and execution, develop advocacy to shape market beliefs and behaviors, and enhance connections with National and Regional Therapeutic Area Experts (TAEs) within their geography. The Senior TLL will demonstrate capabilities to translate TAE insights into actionable feedback to shape brand and squad strategies and execution. The Senior TLL supports pull through of Squad priorities and brand strategies to local/regional Customer Engagement (CE) opportunities and partners with CE leadership to shape advocacy in local markets.
Key Roles & Responsibilities:
* Establish and foster effective partnerships with National and Regional Thought Leaders
* Develop advocacy among National and Regional TAEs to further advance squad and brand priorities
* Ability to understand, integrate, and synthesize insights across customers, competitors, therapeutic or business areas and markets to shape strategic planning and customer impact
* Coordinate and communicate with internal stakeholders (e.g., Squad leadership, customer engagement roles, marketing, USMA network, compliance, and legal) to ensure cohesive and compliant understanding of Therapeutic Area (TA) strategy, priorities, and needs.
* Acts with urgency in ensuring our TAEs are educated on the most up-to-date data and messages for our brands and markets and compliantly correcting any misperceptions
* Partner with medical to lead overarching TAE strategy for brands, indications & launches; each function independently determines final strategies, tactics & activities
* Compliantly manage Fee-for-service activities that include TAEs (selection / pull through as appropriate)
* Effectively influences customer perception and advocacy for current and future products, and leverages relationships with these customers appropriately to meet the needs of all GNE partners (brand marketing, CE, medical, global)
* Actively participates on core Marketing and TLL sub-teams (e.g., ad board planning/execution, insights, congresses)
* Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities
* Accountable for being fully knowledgeable of and compliant with all relevant company policies and procedures, and applicable laws and regulations that govern conduct of GNE activities
* Business travel, by air or car, is regularly required
This is a field based position located in the territory of CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT. Relocation benefits are not provided for this role.
Demonstrates Proficiency within the following Key Competencies
Sr. Thought Leader Liaisons are expected to consistently perform at a proficient level (proficient is defined as leveraging competencies across the business in a consistent, integrated way)
* Customer Understanding - I'm always learning about my customers, what they need, and the world they live in.
* Competitive Value Creation - I determine the relevant, competitive, and profitable value story we offer to customers.
* Strategy Development - I make smart choices about what efforts will help achieve customers' goals and our goals.
* Execution Readiness - I rally the organization to plan, coordinate, and pull through the strategy together.
* Delivery & Optimization Across Channels - I make sure our story is reaching customers in a seamless, memorable experience.
* Measurement & Iteration - I evaluate everything we do, and adjust, stop, or start for continuous improvement.
Knowledge/Skills:
* Deep knowledge of National and Regional TAEs with a preference for strong relationships among TAEs within geography
* Deep knowledge of each customer type (e.g. HCPs, patients, payers, IDNs, distributors, pathways) and how TAEs may engage with various customer types
* Ability to educate and challenge TAEs
* Understanding of partners, their roles and leveraging their expertise to effectively partner, engage, and mobilize key internal stakeholders.
* Ability to articulate business problems and identify solutions
* Direct experiences with interpreting and applying market, customer, product or competitor data and utilizing data effectively for making decisions
* Ability to utilize computer programs to build and share presentations, utilize spreadsheets to decipher important insights, and host virtual meetings with internal stakeholders/customers
* Ability to successfully manage cross-functional projects in collaboration with other internal stakeholders and vendors
* Ability to think with an enterprise mindset
* Ability to influence and inspire individuals and teams across the CMG network, from front-line employees to the executive level
* Ability to flex and thrive in an ambiguous environment undergoing transformational change
* Strong financial acumen and analytical skills to effectively interpret and utilize quantitative and qualitative data
* Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
Who You Are:
Minimum Candidate Qualifications & Experience:
* Bachelors' Degree
* A minimum of 5 years cross-functional industry experience in life sciences (pharma or biotechnology) or related industry (e.g., payers, health systems), is required
Additional Desired Candidate Qualifications & Experience:
* Graduate Level degree
* Immunology experience, specifically across Rheumatology & Nephrology
* Thought Leader Liaison experience
* Previous experience in Commercial functions
* Experience in shaping or influencing marketing strategies, plans, and tactics
* Proven and thorough knowledge of Commercial issues associated with highly competitive therapeutic area
* Proven track record of consistent achievement or overachievement in assigned responsibilities, goals, objectives and any other relevant metrics
* Previous experience building, implementing and seamlessly executing action plans, programs and related activities
Location:
* This is a field based position located in the territory of CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT.
* Relocation benefits are not provided for this role.
* Individual must reside within the territory boundaries given extensive travel requirements of the TLL role
* Approximate travel: 60%+ overnight travel (including weekends)
This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.
The expected salary range for this position based on the primary location of NY is $159,300 - $295,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
Benefits
Roche Operating Principles
* Put Patients First: I always act as if patients I know are in the room and do what's best for them
* Follow the science: I seek answers through experiments, data and debate, and act on facts
* Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part
* Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others
* Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures
* Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less
* Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty
* Think long term: I choose actions today that benefit future generations
#LI-JW2
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
$159.3k-295.8k yearly 15d ago
Packaging Engineer III, Pharmaceutical
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies - dry-powder formulations and inhalation devices - offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication.
Position Summary
Responsible for Package Technology projects necessary to design, develop and transfer cost effective and sound packaging for pharmaceutical products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, handling and tampering.
Essential Responsibilities / Duties
Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Interacts in a team environment as part of the development, transfer and launch project structures, as well as required to work independently on the technical and regulatory tasks necessary to support corporate and team goals.
Design drug product packaging in support of the drug development process by identifying:
* Critical drug product attributes as defined by Development teams
* Commercialization requirements set by Marketing
* Regulatory needs supporting NDA submission, review and approval
* Production efficiency and standards as necessary
* Develop packaging technologies using engineering principles and scientific analysis to collect and synthesize data relating to package and drug product performance.
* Implement package design solutions in a commercial environment, by leading & coordinating project activities, including equipment selection, procurement and qualification and logistics associated with contract packaging sites.
* Support clinical supply activities by designing appropriate drug product packaging.
* Scale up packaging technologies to production by compiling and executing the necessary technical and financial plans.
* Write, create and establish regulatory and purchasing specifications for packaging requirements (components, in process controls) based upon development and transfer activities.
* Coordinate and participate in the launch activities related to packaging which are required to support new product introductions.
* Lead and participate in project teams as required utilizing good communication, analytical, organizational and leadership skills.
* Generate written development and investigational reports in support of package components, materials, equipment and processes. Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Qualifications
* BS Degree in Package Engineering or related field, with a minimum 5-8 years' experience in package engineering in pharmaceuticals or related field, or MS degree with 3-6 years' experience in package engineering in pharmaceutical or related field.
* Working knowledge of materials test methodology, laboratory procedures and packaging equipment.
* Strong organizational skills and ability to manage multiple responsibilities.
* Knowledge of cGMP's and various regulatory aspects affecting pharmaceutical packaging development and operations.
$79k-102k yearly est. 13d ago
IT-Cybersecurity Internship
Mannkind Corporation 4.7
Mannkind Corporation job in Danbury, CT
MannKind MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. With a focus on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, pulmonary fibrosis, nontuberculous mycobacterial (NTM) lung disease, and fluid overload associated with heart failure and chronic kidney disease.
At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.
Why You'll Love This Opportunity:
Make a real impact: You won't just shadow - you'll take ownership of meaningful work that directly strengthens our SharePoint security posture and helps hundreds of employees collaborate safely and efficiently.
Hands‑on learning with modern tools: You'll gain practical experience with Microsoft 365, SharePoint Online, and enterprise‑level governance frameworks-skills that are in high demand and valuable for any IT or cybersecurity career path.
Learn from experienced mentors: You'll work closely with IT Security leaders who are committed to your development, offering guidance, feedback, and opportunities to explore areas you're passionate about.
Grow your technical and professional skills: From permission modeling and access control design to documentation and process improvement, you'll build a strong foundation that will set you apart early in your career.
What You'll Be Doing:
In this role, the intern will support the organization's SharePoint governance and security initiatives through research, analysis, and hands‑on operational work. They will help strengthen the company's Microsoft 365 environment by investigating industry best practices, evaluating governance tools, and assisting with permission cleanup activities. The intern will work closely with IT Security and business teams to improve documentation, streamline processes, and promote secure collaboration across the organization. Their work will directly contribute to better visibility, reduced access risk, and a more scalable, well‑governed SharePoint environment. Clear documentation, reporting, and communication will be essential as they help drive long‑term governance improvements.
Key Activities
* Researching industry best practices for SharePoint Online permissions, governance models, site architecture, and access‑control standards-and summarizing recommendations for the IT Security team.
* Evaluating tools and solutions (native Microsoft 365 features and third‑party options) that can improve permission visibility, governance workflows, and long‑term manageability.
* Reviewing and analyzing SharePoint permissions across sites, libraries, and groups to identify risks, overly broad access, and opportunities for improvement.
* Supporting governance initiatives by helping update documentation, refine policies, and streamline processes related to site ownership, lifecycle management, and compliance requirements.
* Assisting with permission cleanup efforts, including fixing broken inheritance, resolving inconsistent access, and helping move teams toward least‑privilege access models.
* Partnering with site owners and business teams to understand their needs, answer questions, and provide guidance on secure, effective collaboration practices.
* Creating reports and dashboards that help track site activity, permission changes, and overall governance health using Microsoft 365 tools.
* Documenting findings, decisions, and procedures so the team can maintain clarity, audit readiness, and long‑term operational continuity.
What You Bring to the Table:
Currently pursuing a degree in Information Technology, Computer Science, or a related field.
Commit to working 40 hours per week for the full 8-12 weeks without vacation weeks.
Bonus Points If You Have:
* Preferably within 1-2 years of graduation
* Knowledge of co-pilot AI to help build workflows
* Strong analytical, interpersonal, organizational, and problem-solving skills
* Excellent attention to detail and ability to work independently
* Strong research skills that can reach out to vendors and get the problem statement across to them in a clear and concise manner
* Proficiency in Microsoft Sharepoint
* Strong written and verbal communication skills
* Self-motivated and demonstrated learning agility
* You take the initiative to identify opportunities for improvement and act on them without needing constant direction.
* You are open to constructive criticism and use it to improve performance and grow professionally
When and Where You'll Shine:
* Full-time: Schedule (Onsite Mon-Thu, Remote Fri)
* Location: Danbury, CT
* Dates of Program: June 15 to August 20, 2026
* A reliable commute or the intention to find temporary housing before starting the internship is required.
At this time, we are only able to consider candidates who do not require visa sponsorship, including those with a student visa.
$34k-42k yearly est. 7d ago
Senior Thought Leader Liaison, Immunology
Genentech 4.5
Bridgeport, CT job
** **Senior Thought Leader Liaison, Immunology** **Why Genentech** We're passionate about delivering on Our Promise (****************************************** to improve the lives of patients and create healthier communities for all. We foster a culture of inclusivity, integrity and creativity while boldly pursuing answers to the world's most complex health challenges and transforming society.
**About this Marketing Role:**
The Senior TLL role at Genentech is a crucial link between the company and National & Regional Therapeutic Area Experts (TAEs) across Immunology. The Senior TLL will garner insights to refine strategy and execution, develop advocacy to shape market beliefs and behaviors, and enhance connections with National and Regional Therapeutic Area Experts (TAEs) within their geography. The Senior TLL will demonstrate capabilities to translate TAE insights into actionable feedback to shape brand and squad strategies and execution. The Senior TLL supports pull through of Squad priorities and brand strategies to local/regional Customer Engagement (CE) opportunities and partners with CE leadership to shape advocacy in local markets.
**Key Roles & Responsibilities:**
+ Establish and foster effective partnerships with National and Regional Thought Leaders
+ Develop advocacy among National and Regional TAEs to further advance squad and brand priorities
+ Ability to understand, integrate, and synthesize insights across customers, competitors, therapeutic or business areas and markets to shape strategic planning and customer impact
+ Coordinate and communicate with internal stakeholders (e.g., Squad leadership, customer engagement roles, marketing, USMA network, compliance, and legal) to ensure cohesive and compliant understanding of Therapeutic Area (TA) strategy, priorities, and needs.
+ Acts with urgency in ensuring our TAEs are educated on the most up-to-date data and messages for our brands and markets and compliantly correcting any misperceptions
+ Partner with medical to lead overarching TAE strategy for brands, indications & launches; each function independently determines final strategies, tactics & activities
+ Compliantly manage Fee-for-service activities that include TAEs (selection / pull through as appropriate)
+ Effectively influences customer perception and advocacy for current and future products, and leverages relationships with these customers appropriately to meet the needs of all GNE partners (brand marketing, CE, medical, global)
+ Actively participates on core Marketing and TLL sub-teams (e.g., ad board planning/execution, insights, congresses)
+ Works autonomously to make decisions and act, in close alignment with the full product value proposition, customer positioning, and Squad priorities
+ Accountable for being fully knowledgeable of and compliant with all relevant company policies and procedures, and applicable laws and regulations that govern conduct of GNE activities
+ Business travel, by air or car, is regularly required
**This is a field based position located in the territory of** **CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT.** **Relocation benefits are not provided for this role.**
**Demonstrates Proficiency within the following Key Competencies**
Sr. Thought Leader Liaisons are expected to consistently perform at a proficient level (proficient is defined as leveraging competencies across the business in a consistent, integrated way)
+ **Customer Understanding** - I'm always learning about my customers, what they need, and the world they live in.
+ **Competitive Value Creation** - I determine the relevant, competitive, and profitable value story we offer to customers.
+ **Strategy Development** - I make smart choices about what efforts will help achieve customers' goals and our goals.
+ **Execution Readiness** - I rally the organization to plan, coordinate, and pull through the strategy together.
+ **Delivery & Optimization Across Channels** - I make sure our story is reaching customers in a seamless, memorable experience.
+ **Measurement & Iteration** - I evaluate everything we do, and adjust, stop, or start for continuous improvement.
**Knowledge/Skills:**
+ Deep knowledge of National and Regional TAEs with a preference for strong relationships among TAEs within geography
+ Deep knowledge of each customer type (e.g. HCPs, patients, payers, IDNs, distributors, pathways) and how TAEs may engage with various customer types
+ Ability to educate and challenge TAEs
+ Understanding of partners, their roles and leveraging their expertise to effectively partner, engage, and mobilize key internal stakeholders.
+ Ability to articulate business problems and identify solutions
+ Direct experiences with interpreting and applying market, customer, product or competitor data and utilizing data effectively for making decisions
+ Ability to utilize computer programs to build and share presentations, utilize spreadsheets to decipher important insights, and host virtual meetings with internal stakeholders/customers
+ Ability to successfully manage cross-functional projects in collaboration with other internal stakeholders and vendors
+ Ability to think with an enterprise mindset
+ Ability to influence and inspire individuals and teams across the CMG network, from front-line employees to the executive level
+ Ability to flex and thrive in an ambiguous environment undergoing transformational change
+ Strong financial acumen and analytical skills to effectively interpret and utilize quantitative and qualitative data
+ Embraces change, embodies a continuous improvement mindset, and exemplifies agile principles in day-to-day activities
**Who You Are:**
**Minimum Candidate Qualifications & Experience:**
+ Bachelors' Degree
+ A minimum of 5 years cross-functional industry experience in life sciences (pharma or biotechnology) or related industry (e.g., payers, health systems), is required
**Additional Desired Candidate Qualifications & Experience:**
+ Graduate Level degree
+ Immunologyexperience, specifically across Rheumatology & Nephrology
+ Thought Leader Liaison experience
+ Previous experience in Commercial functions
+ Experience in shaping or influencing marketing strategies, plans, and tactics
+ Proven and thorough knowledge of Commercial issues associated with highly competitive therapeutic area
+ Proven track record of consistent achievement or overachievement in assigned responsibilities, goals, objectives and any other relevant metrics
+ Previous experience building, implementing and seamlessly executing action plans, programs and related activities
**Location:**
+ This is a field based position located in the territory of CT, DE, MA, ME, NH, NJ, NY, PA, RI, VT.
+ Relocation benefits are not provided for this role.
+ Individual must reside within the territory boundaries given extensive travel requirements of the TLL role
+ Approximate travel: 60%+ overnight travel (including weekends)
This position requires significant driving of either a company provided or personal vehicle as well as prolonged periods of sitting, both of which are part of the essential duties and responsibilities of the role. As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business.
The expected salary range for this position based on the primary location of NY is $159,300 - $295,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
**Benefits (******************************************************
**Roche Operating Principles**
+ Put Patients First: I always act as if patients I know are in the room and do what's best for them
+ Follow the science: I seek answers through experiments, data and debate, and act on facts
+ Act as one team: I care, collaborate and commit without boundaries, and trust others to do their part
+ Embrace differences: I seek diverse perspectives, invite opposing views, and challenge myself and others
+ Accelerate learning: I push to learn new things even if difficult, and openly share my successes and failures
+ Simplify radically: I eliminate complexity, reuse with pride, and accomplish more with less
+ Make impact now: I take accountability to do what's right, deliver value fast, and don't wait for certainty
+ Think long term: I choose actions today that benefit future generations
\#LI-JW2
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .
Zippia gives an in-depth look into the details of MannKind, including salaries, political affiliations, employee data, and more, in order to inform job seekers about MannKind. The employee data is based on information from people who have self-reported their past or current employments at MannKind. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by MannKind. The data presented on this page does not represent the view of MannKind and its employees or that of Zippia.
MannKind may also be known as or be related to MANNKIND CORP, MannKind, MannKind Corp., MannKind Corporation, Mannkind and Mannkind Corporation.